Document 20617

Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʣʲʮʤʴʥʷʺʡʥʮʹʸʰʹʭʩʸʩʹʫʺ
ʭʩʹʣʧʭʩʸʩʹʫʺʥʮʹʸʰʫ
ʤʱ
ʯʸʶʩ
B.BRAUN MEDICAL S.A., SPAIN
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
BIOAVENIR LTD
I.V
ʸʩʹʫʺʭʹ
FLUCONAZOL
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
09/06/2009
140-93-31445-00
&U\SWRFRFFRVLV
6\VWHPLFFDQGLGLDVLVPXFRVDOFDQGLGLDVLV
FLUCONAZOLE 2 MG/ML
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE GLASS TYPE I 50 ML; BOTTLE GLASS TYPE I 100 ML; BOTTLE GLASS TYPE I 200 ML
HAUPT PHARMA MUNSTER GmbH, GERMANY
ABIC MARKETING LTD
PER OS
SHELLY
09/06/2009
Oral contraception.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ETHINYLESTRADIOL 0.03 MG ; GESTODENE 0.075 MG
BLISTER 1 x 21 TABLETS; BLISTER 3 x 21 TABLETS
HAUPT PHARMA MUNSTER GmbH, GERMANY
ABIC MARKETING LTD
PER OS
EMILY
09/06/2009
Oral contraception.
BLISTER 1 x 21 TABLETS; BLISTER 3 x 21 TABLETS
TEVA PHARMACEUTICAL INDUST.LTD
OCULAR
DORZOLAMIDE TIMOLOL TEVA
09/06/2009
For the treatment of elevated intracular pressure (IOP) in patients with ocular hypertension, open-angle glaucoma, or other secondary open-angle glaucoma, when concomitant
therapy is appropriate.
DORZOLAMIDE AS HYDROCHLORIDE 2% ; TIMOLOL AS MALEATE 0.5%
BOTTLE LDPE 5 ML
PHARMASCIENCE INC., CANADA
RAFA LABORATORIES LTD
140-87-31769-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
GESTODENE 0.075 MG ; ETHINYLESTRADIOL 0.02 MG
TEVA PHARMACEUTICAL INDUSTRIES LTD
140-88-31770-00
PER OS
RAMIRIL PLUS 5 MG/25 MG
Essential hypertension. Ramiril Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone.
RAMIPRIL 5 MG ; HYDROCHLOROTHIAZIDE 25 MG
BLISTER 30
ʪʥʺʮʣʥʮʲ
09/06/2009
140-91-31699-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
140-89-31826-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
PHARMASCIENCE INC., CANADA
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
RAFA LABORATORIES LTD
PER OS
ʸʩʹʫʺʭʹ
RAMIRIL PLUS 2.5 MG/12.5 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
09/06/2009
140-90-31827-00
Essential hypertension. Ramiril Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
RAMIPRIL 2.5 MG ; HYDROCHLOROTHIAZIDE 12.5 MG
BLISTER 30
STIEFEL LABORATORIES (IRELAND) LTD
PERRIGO ISRAEL AGENCIES LTD
TOPICAL
DUAC ®
09/06/2009
Mild to moderate acne vulgaris, particulary inflammatory lesions.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
CLINDAMYCIN PHOSPHATE 1.28 %W/W ; BENZOYL PEROXIDE HYDROUS 6.67 %W/W
TUBE 25 G
SAM-ON LTD., BAT-YAM
SAM-ON LTD
PER OS
KALBETEN FORTE CAPLETS
18/06/2009
Relief of diarrhea, nausea, flatulence, convulsive stomach pains, uspet stomach. As a preventative treatment of traveler's diarrhea.
BLISTER 10 ; BLISTER 20
TARO PHARMACEUTICAL INDUSTRIES LTD
TARO PHARMACEUTICAL INDUSTRIES
PER OS
LTD
Treatment of primary generalised tonic - clonic seizures and partial seizures with or without secondary generalization.
TREXAPIN 150
18/06/2009
BLISTER 50 TABLETS
PER OS
KALETRA 100 MG/25 MG
TABLETS
01/07/2009
Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections.
BOTTLE HDPE 60 TABLETS
DEXCEL LTD
141-07-32003-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
LOPINAVIR 100 MG ; RITONAVIR 25 MG
DEXCEL LTD
140-96-31747-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
OXCARBAZEPINE 150 MG
ABBOTT LABORATORIES S.A.
140-95-31841-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BISMUTH SUB SALICYLATE 524 MG
ABBOTT LABORATORIES LTD., ENGLAND
140-92-31439-00
PER OS
VASODIP COMBO 10
Treatment of essential hypertension in whose blood pressure cannot be adequately controlled under Lercanidipine monotherapy.
01/07/2009
141-06-31726-00
ʤʩʥʥʺʤ
LERCANIDIPINE HYDROCHLORIDE 10 MG ; ENALAPRIL MALEATE 10 MG
ʭʩʡʩʫʸʮ
BLISTER PA/ALUMINIUM/PVC 10 ; BLISTER PA/ALUMINIUM/PVC 14 ; BLISTER PA/ALUMINIUM/PVC 15 ; BLISTER PA/ALUMINIUM/PVC 20 ; BLISTER PA/ALUMINIUM/PVC ʺʥʦʩʸʠ
28 ; BLISTER PA/ALUMINIUM/PVC 30
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
DEXCEL LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
DEXCEL LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
VASODIP COMBO 20
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
01/07/2009
141-05-31727-00
Treatment of essential hypertension in patients whose blood pressure cannot be adequately controlled under Enalapril monotherapy.
ʤʩʥʥʺʤ
LERCANIDIPINE HYDROCHLORIDE 10 MG ; ENALAPRIL MALEATE 20 MG
ʭʩʡʩʫʸʮ
BLISTER PA/ALUMINIUM/PVC 10; BLISTER PA/ALUMINIUM/PVC 14; BLISTER PA/ALUMINIUM/PVC 15; BLISTER PA/ALUMINIUM/PVC 20; BLISTER PA/ALUMINIUM/PVC 28; ʺʥʦʩʸʠ
BLISTER PA/ALUMINIUM/PVC 30
MERCK SHARP & DOHME (ITALIA) S.P.A.
MERCK SHARP & DOHME ISRAEL LTD
PER OS
FOSAVANCE 70/5600 TABLETS
01/07/2009
140-99-31792-00
Fosavance is indicated for : Treatment of Osteoporosis in postmenopausal women: for the treatment of osteoporosis, Fosavance increases bone mass and reduces the incidence of ʤʩʥʥʺʤ
fractures, including those of the hip and spine (vertebral compression fractures). Treatment to increase bone mass in men with osteoporosis.
CHOLECALCIFEROL 140 MCG ; ALENDRONIC ACID ANHYDROUS AS ALENDRONATE SODIUM TRIHYDRATE 70 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 2 TABLETS; BLISTER 4 TABLETS
SANOFI PASTEUR S.A., FRANCE
MEDICI LTD
I.M
VERORAB
01/07/2009
Prevention of rabies in children and adults. It can be used before and after exposure, as a primary vaccination or as a booster dose.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
RABIES, INACTIVATED, WHOLE VIRUS 2.5 IU
VIAL GLASS TYPE I 3 ML; VIAL GLASS TYPE I 3 ML
SANOFI PASTEUR LTD, CANADA
MEDICI LTD
PEDIACEL
140-97-31875-00
01/07/2009
141-01-31746-00
Pediacel is indicated for immunization of children at or above the age of 2 months and as a booster in children up to their 7th birthday against diphtheria, tetanus, whooping cough, ʤʩʥʥʺʤ
poliomyelitis and invasive Haemophilus influenzae type b disease. In infants, three infectons are to be given intramuscularly at 2, 4 and 6 months of age followed by a booster at 18
months of age. Children who have had pertusis, tetanus, diphtheria or haemophilus influenzae type b invasive disease should still be immunized since these clinical infections do not
always confer immunity. Children who have had natural pertussis can continue to receive pertussis - containing vaccines. Human immunodeficiency virus (HIV) infected persons HIV
- infected individuals, both asymptomatic and symptomatic, should be immunized with Pediacel vaccine according to standard schedules.
PERTACTIN (PRN) 3 MCG ML ; DIPHTHERIA TOXOID 15LF ML ; TETANUS TOXOID 5LF ML ; PERTUSSIS TOXOID VACCINE 20 MCG ML ; FILAMENTOUS
ʭʩʡʩʫʸʮ
HAEMOGGLUTININ (FHA) 20 MCG ML ; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG ML ; POLIOVIRUS TYPE 1 40DU ML ; POLIOVIRUS TYPE 2 8DU ML ; POLIOVIRUS TYPE 3
32DU ML ; PRP OF HAEMOPHILUS INFL. TYPE B 10 MCG ML
VIAL 1 x 0.5 ML; VIAL 5 x 0.5 ML
ʺʥʦʩʸʠ
FLORIS LTD
FLORIS LTD
DERMAL
For the disinfection of skin infections and inflammations, wounds and superficial burns.
IODIFLOR OINTMENT
01/07/2009
141-02-31802-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
POVIDONE-IODINE 10%
BOTTLE HDPE 250 G; TUBE LDPE 15 G; TUBE LFPE 50 G
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
FLORIS LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
FLORIS LTD
ʯʥʰʩʮʺʸʥʶ
DERMAL
ʸʩʹʫʺʭʹ
POLYSKIN OINTMENT (LIFE)
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
01/07/2009
141-03-31804-00
For the disinfection of skin infections and inflammations, wounds and superficial burns.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
POVIDONE-IODINE 10%
TUBE LDPE 15 G; TUBE LFPE 50 G
KELA N.V. BELGIUM
M.P.VET LTD
PER OS IN DRINKING
AMOXYKEL 70 SOLUBLE
WATER
POWDER VETERINARY
Amoxykel 70 is indicated for the treatment of infections caused by microorganisms sensitive to Amoxicillin in broilers and pigs.
01/07/2009
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
AMOXICILLIN AS TRIHYDRATE 1G/DOSE
BAG ALUMINIUM 100 G; BAG ALUMINIUM 1000 G
PERRIGO COMPANY, USA
PERRIGO ISRAEL AGENCIES LTD
TOPICAL
FLEXIDERM
01/07/2009
Temporarily relieves the minor aches and pains of muscles and joints associated with simple bacaches, arthritis, strains, bruises and sprains.
TUBE 113 G
LUXEMBURG PHARMACEUTICALS LTD
I.V
FERROVIN
140-98-31745-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
CAMPHOR 4% ; MENTHOL 10% ; METHYL SALICYLATE 30%
RAFARM S.A., GREECE
140-94-92422-00
01/07/2009
141-09-31806-00
Severe iron deficiency only when oral administration has been found impossible. In cases of gastro- intestinal malobsorption which rules our oral therapy, patients on dialysis treated ʤʩʥʥʺʤ
with erythropoietin.
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
IRON SUCROSE 20MG/ML
AMPOULES GLASS TYPE I 5
ABBOTT LABORATORIES LTD., ENGLAND
ABBOTT LABORATORIES S.A.
PER OS
ZEMPLAR 1 MICROGRAM
19/07/2009
141-12-31816-00
Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients ʤʩʥʥʺʤ
and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis.
PARICALCITOL 1 MCG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 7 CAPSULES; BLISTER 28 CAPSULES
ABBOTT LABORATORIES LTD., ENGLAND
ABBOTT LABORATORIES S.A.
PER OS
ZEMPLAR 2 MICROGRAM
19/07/2009
141-13-31817-00
Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients ʤʩʥʥʺʤ
and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis.
PARICALCITOL 2 MCG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 7 CAPSULES; BLISTER 28 CAPSULES
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ABBOTT LABORATORIES LTD., ENGLAND
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ABBOTT LABORATORIES S.A.
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
ZEMPLAR 4 MICROGRAM
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
19/07/2009
141-14-31818-00
Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients ʤʩʥʥʺʤ
and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis.
PARICALCITOL 4 MCG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 7 CAPSULES; BLISTER 28 CAPSULES
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD
UNIPHARM LTD
PER OS
RISPOND SOLUTION
20/07/2009
141-17-31711-00
Rispond is indicated for the management of schizophrania and manifestation of psychotic disorders. The antipsychotic efficacy of Rispond was established in short-term (6 to 8
ʤʩʥʥʺʤ
weeks) controlled trials of schizophrenic inpatients. Rispond is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an
initial treatment response. Rispond is indicated for the treatment of psychotic manifestations of dementia. Conduct and other disruptive disorders: Treatment of behavioral
disorders expressed by impulse control disorders or self-alienated-aggressive or treatment- requiring behavioral disorders with reduced or substandard intelligence. Treatment
should not be given to children under the age of 5 years. Rispond is indicated for the treatment of mania in bipolar disorder. These episodes are characterized by symptoms such
as elevated expansive or irritable mood inflated self-esteem decreased need for sleep pressured speech racing thoughts distractibility or poor judgment including disruptibe or
aggressive behaviors.
ʭʩʡʩʫʸʮ
RISPERIDONE 1MG/ML
ʺʥʦʩʸʠ
BOTTLE AMBER GLASS III 30 ML; BOTTLE AMBER GLASS III 100 ML
RAFA LABORATORIES LTD, JERUSALEM
RAFA LABORATORIES LTD
PER OS
RAMITENS PLUS 2.5 MG/12.5 MG
20/07/2009
Essential hypertension. Ramitens Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
RAMIPRIL 2.5 MG ; HYDROCHLOROTHIAZIDE 12.5 MG
BLISTER 30 TABLETS
RAFA LABORATORIES LTD, JERUSALEM
RAFA LABORATORIES LTD
PER OS
RAMITENS PLUS 5 MG/25 MG
20/07/2009
Essential hypertension. Ramitens Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone.
BLISTER 30 TABLETS
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
METFORMIN TEVA ®
141-16-31689-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
RAMIPRIL 5 MG ; HYDROCHLOROTHIAZIDE 25 MG
TEVA PHARMACEUTICAL INDUSTRIES LTD
141-15-31688-00
31/07/2009
Metformin Teva is indicated in diet - failed non - insulin dependent diabetic patients especially if overweight either alone as initial therapy or in combination with a sulfonylurea.
Occasionally as adjuvant therapy in insulin - dependent diabetic patients particularly who are usually obese and not well controlled with insulin.
130-25-30822-13
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
METFORMIN HYDROCHLORIDE 850 MG
BLISTER PVDC/ALUMINIUM 30
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
JANSSEN PHARMACEUTICA N.V.,BELGIUM
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ABIC VETERINARY PRODUCTS LTD
PER OS
ʸʩʹʫʺʭʹ
YARVITAN VETERINARY
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
31/07/2009
141-08-92425-00
As an aid in management of overweight and obesity in dogs.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
MITRATAPIDE 5MG/ML
BOTTLE AMBER GLASS 55 ML; BOTTLE AMBER GLASS 120 ML; BOTTLE AMBER GLASS 210 ML
SCHERING GmbH & Co.PRODUKTIONS KG
BAYER ISRAEL LTD
PER OS
YAZ
31/07/2009
141-04-32023-00
2UDOFRQWUDFHSWLRQ
ʤʩʥʥʺʤ
7UHDWPHQWRIPRGHUDWHDFQHYXOJDULVLQZRPHQZKRVHHNRUDOFRQWUDFHSWLRQ
7UHDWPHQWRIV\PSWRPVRISUHPHQVWUXDOG\VSKRULFGLVRUGHU30''LQZRPHQZKRKDYHFKRVHQRUDOFRQWUDFHSWLYHVDVWKHLUPHWKRGRIELUWKFRQWURO7KHHIILFDF\RI<D]IRU30''
ZDVQRWDVVHVVHGEH\RQGF\FOHV<D]KDVQRWEHHQHYDOXDWHGIRUWUHDWPHQWRI306SUHPHQVWUXDOV\QGURPH
DROSPIRENONE 3 MG ; ETHINYLESTRADIOL 0.02 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 6 x 28 TABLETS; BLISTER 1 x 28 TABLETS; BLISTER 3 x 28 TABLETS
RIVOPHARM SA, SWITZERLAND
PERRIGO ISRAEL AGENCIES LTD
PER OS
ALFU-KAL XL
01/08/2009
Treatment of certain functional symptoms of benign prostatic hypertrophy, particularly if surgery has to be delayed for some reason.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ALFUZOSIN HYDROCHLORIDE 10 MG
BLISTER 30 TABLETS
CTS CHEMICAL INDUSTRIES LTD
CTS CHEMICAL INDUSTRIES LTD
PER OS
LOSARTAN PLUS
141-23-31829-00
01/08/2009
141-24-31703-00
For the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
HYDROCHLOROTHIAZIDE 12.5 MG ; LOSARTAN AS POTASSIUM 50 MG
BLISTER 7 TABLETS; BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS; BLISTER 100 TABLETS
MAX ZELLER SOHNE, SWITZERLAND
RAFA LABORATORIES LTD
PER OS
REMOTIV 500
01/08/2009
Symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping
through the night which is associated with these conditions.
HYPERICI HERBA EXTRACTUM SICCUM 500 MG
BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 60 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 120 TABLETS; BLISTER
PVC/PVDC/ALUMINIUM 10 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
DONEPEZIL TEVA ® 10 MG
Treatment of mild to moderately severe Alzheimer's dementia.
01/08/2009
141-28-31607-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-26-31461-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
DONEPEZIL HYDROCHLORIDE 10 MG
BLISTER 30 TABLETS
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
ʸʩʹʫʺʭʹ
DONEPEZIL TEVA ® 5 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
01/08/2009
141-25-31460-00
Treatment of mild to moderately severe Alzheimer's dementia.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
DONEPEZIL HYDROCHLORIDE 5 MG
BLISTER 30 TABLETS
ULTRADENT PRODUCTS INC, USA
R.N . DENTO MEDICAL DIVISION LTD
LOCAL ORAL
ULTRACARE (BUBBLE GUM
01/08/2009
141-27-31937-00
FLAVOR)
For any dental procedure in which topical anesthesia is desired. For temporary relief of pain associated with : canker sores dental procedures minor injury of the mouth and gum ʤʩʥʥʺʤ
caused by dentures or orthodentic appliances.
BENZOCAINE 20 %W/V
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE PLASTIC 30 ML; SYRINGE POLYPROPYLENE 30 ML; SYRINGE POLYPROPYLENE 1.2 ML
UNIGENE LABORATORIES INC., USA
TZAMAL BIO-PHARMA LTD
NASAL
FORTICAL
10/08/2009
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LQGLFDWHGIRUWKHWUHDWPHQWRISRVWPHQRSDXVDORVWHRSRURVLVLQZRPHQJUHDWHUWKDQ\HDUV
SRVWPHQRSDXVHZLWKORZERQHPDVVUHODWLYHWRKHDOWK\SUHPHQRSDXVDOZRPHQ8VHRI)257,&$/Š
FDOFLWRQLQVDOPRQU'1$RULJLQ1DVDO6SUD\LVUHFRPPHQGHGLQFRQMXQFWLRQZLWKDQDGHTXDWH
FDOFLXPDWOHDVWPJHOHPHQWDOFDOFLXPSHUGD\DQG9LWDPLQ',QWHUQDWLRQDO8QLWVSHU
GD\LQWDNHWRUHWDUGWKHSURJUHVVLYHORVVRIERQHPDVV7KHHYLGHQFHRIHIILFDF\IRUFDOFLWRQLQVDOPRQ
LVEDVHGRQLQFUHDVHVLQVSLQDOERQHPLQHUDOGHQVLW\%0'REVHUYHGLQFOLQLFDOWULDOV
CALCITONIN SALMON 200IU/DOSE
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL AMBER GLASS TYPE I 3.7 ML
JANSSEN CILAG S.P.A., ITALY
J-C HEALTH CARE LTD
141-31-31800-00
PER OS
INTELENCE
10/08/2009
141-29-31789-00
Intelence is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment ʤʩʥʥʺʤ
-experienced adult patients including those with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. Treatment history and when available resistance testing
should guide the use of Intelence. In patients who have experienced virological failure on an NNRTI- and nucleoside or nucleotide reverse transcriptase inhibitor (N[t]RTI)- containing
regimen Intelence is not recommended for use in combination with N(t)RTIs only.
ETRAVIRINE 100 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE 120 TABLETS
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD
TRIMA ISRAEL PHARMACEUTICAL
PRODUCTS MAABAROT LTD
Parkinson's disease. Combination therapy with L-dopa and as monotherapy for newly diagnosed illness.
PER OS
CABERGOLINE 2 MG
BOTTLE POLYETHYLENE 30 TABLETS
ʪʥʺʮʣʥʮʲ
CABOTRIM 2
10/08/2009
141-30-32035-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
TEVA PHARMACEUTICAL INDUST.LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
ANASTROZOLE TEVA ®
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
10/08/2009
141-32-31760-00
Treatment of advanced breast cancer in post menopausal women. Efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive
ʤʩʥʥʺʤ
clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer
in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
ANASTROZOLE 1 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVDC/ALUMINIUM 30 TABLETS
ALZA CORPORATION, USA
J-C HEALTH CARE LTD
PER OS
JURNISTA 4 MG
11/08/2009
141-42-31956-00
Treatment of severe pain.
ʤʩʥʥʺʤ
HYDROMORPHONE HYDROCHLORIDE 4 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/ACLAR 7 TABLETS; BLISTER PVC/ACLAR 10 TABLETS; BLISTER PVC/ACLAR 14 TABLETS; BLISTER PVC/ACLAR 20 TABLETS; BLISTER PVC/ACLAR 28 ʺʥʦʩʸʠ
TABLETS; BLISTER PVC/ACLAR 30 TABLETS; BLISTER PVC/ACLAR 35 TABLETS; BLISTER PVC/ACLAR 40 TABLETS; BLISTER PVC/ACLAR 50 TABLETS; BLISTER
PVC/ACLAR 56 TABLETS; BLISTER PVC/ACLAR 60 TABLETS; BLISTER PVC/ACLAR 100 TABLETS
GLAXO SMITH KLINE MANUFACTURING
GLAXO SMITH KLINE (ISRAEL) LTD
PER OS
HYCAMTIN 1 MG
11/08/2009
SPA,ITALY
Indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
TOPOTECAN HYDROCHLORIDE 1 MG
BLISTER PVC/PCTFE 10 CAPSULES
GLAXO SMITH KLINE MANUFACTURING
GLAXO SMITH KLINE (ISRAEL) LTD
PER OS
HYCAMTIN 0.25 MG
SPA,ITALY
Indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
11/08/2009
BLISTER PVC/PCTFE 10 CAPSULES
SANOFI - AVENTIS ISRAEL LTD
I.V
CLEXANE
11/08/2009
Treatment of acute ST-segment elevation myocardial infarction, in combination with a thrombolytic agent in patients eligible or not for subsequent coronary angioplasty.
ENOXAPARIN SODIUM 100 MG/ML
VIAL GLASS TYPE I 1 x 3 ML
ʪʥʺʮʣʥʮʲ
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-37-31862-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
TOPOTECAN HYDROCHLORIDE 0.25 MG
SANOFI AVENTIS S.A., SPAIN
141-38-31863-00
141-41-32031-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
MERCK KGaA, GERMANY
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
MERCK SERONO LTD
ʯʥʰʩʮʺʸʥʶ
I.V
ʸʩʹʫʺʭʹ
ERBITUX 5 MG/ML
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
11/08/2009
141-40-31828-00
(UELWX[LVLQGLFDWHGIRUWKHWUHDWPHQWRISDWLHQWVZLWK.5$6ZLOGW\SHPHWDVWDWLFFRORUHFWDOFDQFHU
‡LQFRPELQDWLRQZLWKFKHPRWKHUDS\
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(UELWX[LVLQGLFDWHGIRUWKHWUHDWPHQWRISDWLHQWVZLWKVTXDPRXVFHOOFDQFHURIWKHKHDGDQGQHFN6&&+1
‡LQFRPELQDWLRQZLWKUDGLDWLRQWKHUDS\IRUORFDOO\DGYDQFHGGLVHDVH
‡LQFRPELQDWLRQZLWKSODWLQXPEDVHGFKHPRWKHUDS\IRUUHFXUUHQWDQGRUPHWDVWDWLFGLVHDVH
‡DVDVLQJOHDJHQWDIWHUIDLOXUHRISODWLQXPEDVHGFKHPRWKHUDS\IRUUHFXUUHQWDQGRUPHWDVWDWLFGLVHDVH
CETUXIMAB 5 MG/ML
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 10 ML; VIAL GLASS TYPE I 20 ML; VIAL GLASS TYPE I 50 ML; VIAL GLASS TYPE I 100 ML
CSL BEHRING GmbH, GERMANY
MEDILINE LTD.
I.V
HAEMOCOMPLETTAN P 2 G
11/08/2009
+DHPRFRPSOHWWDQ3JJ)LEULQRJHQ&RQFHQWUDWH+XPDQLVLQGLFDWHGIRUWKHWUHDWPHQWRIDFXWHEOHHGLQJHSLVRGHVLQSDWLHQWVZLWKFRQJHQLWDOILEULQRJHQGHILFLHQF\LQFOXGLQJ
DILEULQRJHQHPLDDQGK\SRILEULQRJHQHPLD
+DHPRFRPSOHWWDQ3JJLVQRWLQGLFDWHGIRUG\VILEULQRJHQHPLD
HUMAN FIBRINOGEN 1800 MG / 1 VIALS
VIAL GLASS TYPE II 2 G
KELA N.V. BELGIUM
M.P.VET LTD
PER OS IN DRINKING
WATER
Tylosin 75 is indicated for the treatment of infections caused by microorganisms sensitive to Tylosin in pigs.
TYLOSIN -75 SOLUBLE POWDER
VETERINARY
11/08/2009
BAG ALUMINIUM 133 G; BAG ALUMINIUM 1333 G
MEDILINE LTD.
I.V
HAEMOCOMPLETTAN P 1 G
11/08/2009
+DHPRFRPSOHWWDQ3JJ)LEULQRJHQ&RQFHQWUDWH+XPDQLVLQGLFDWHGIRUWKHWUHDWPHQWRIDFXWHEOHHGLQJHSLVRGHVLQSDWLHQWVZLWKFRQJHQLWDOILEULQRJHQGHILFLHQF\LQFOXGLQJ
DILEULQRJHQHPLDDQGK\SRILEULQRJHQHPLD
+DHPRFRPSOHWWDQ3JJLVQRWLQGLFDWHGIRUG\VILEULQRJHQHPLD
HUMAN FIBRINOGEN 900 MG / 1 VIALS
VIAL GLASS TYPE II 1 G
KOFFOLK (1949) LTD
KOFFOLK (1949) LTD
PER OS
AMPROSOL VETERINARY
11/08/2009
Treatment and prevention of coccidiosis in broilers and lambs.
AMPROLIUM 215 G
BAG METALIC POLYETHYLENE 0.5 KG; BAG METALIC POLYETHYLENE 1 KG; BAG METALIC POLYETHYLENE 2 KG; BAG METALIC POLYETHYLENE 5 KG; BAG
METALIC POLYETHYLENE 15 KG; BAG METALIC POLYETHYLENE 20 KG; BAG METALIC POLYETHYLENE 25 KG
ʪʥʺʮʣʥʮʲ
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-34-92421-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
TYLOSIN AS TARTRATE 750000 IU/DOSE
CSL BEHRING GmbH, GERMANY
141-36-31820-00
141-35-31819-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-39-92423-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
WEST PHARMA- PROD. DE ESPEC.
BIOAVENIR LTD
PER OS
TIASAR 50 MG
03/09/2009
141-46-31613-00
FARMACEUT.S.A.
Hypertension: Losartan is indicated for the treatment of heart failure ( NYHA II and III) usually in addition to diuretics and/or digitalis if use of an ACE inhibitor is not appropriate.
ʤʩʥʥʺʤ
Switching patients with heart failure who are stable on an ACE inhibitor to Tiasar is not recommended. Renal protection in Type - 2 diabetic patients with proteinuria: Losartan is
indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine end stage renal disease ( need for dialysis
or renal transplantation) or death and to reduce proteinuria. Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrphy.
Losartan is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death stroke and myocardial infarction in
hypertensive patients with left ventricular hypertrphy. The benefit of Tiasar on the primary deposite end point was largely driven by reduction in the risk of stroke.
LOSARTAN AS POTASSIUM 50 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS
WEST PHARMA- PROD. DE ESPEC.
BIOAVENIR LTD
PER OS
TIASAR 100 MG
03/09/2009
141-47-31614-00
FARMACEUT.S.A.
Hypertension: Losartan is indicated for the treatment of heart failure ( NYHA II and III) usually in addition to diuretics and/or digitalis if use of an ACE inhibitor is not appropriate.
ʤʩʥʥʺʤ
Switching patients with heart failure who are stable on an ACE inhibitor to Tiasar is not recommended. Renal protection in Type - 2 diabetic patients with proteinuria: Losartan is
indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine end stage renal disease ( need for dialysis
or renal transplantation) or death and to reduce proteinuria. Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrphy.
Losartan is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death stroke and myocardial infarction in
hypertensive patients with left ventricular hypertrphy. The benefit of Tiasar on the primary deposite end point was largely driven by reduction in the risk of stroke.
LOSARTAN AS POTASSIUM 100 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS
WEST PHARMA- PROD. DE ESPEC.
BIOAVENIR LTD
PER OS
COTIASAR
03/09/2009
141-48-31634-00
FARMACEUT.S.A.
For the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
HYDROCHLOROTHIAZIDE 12.5 MG ; LOSARTAN AS POTASSIUM 50 MG
BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
LEVETIRACETAM TEVA ® 1000
03/09/2009
141-45-31783-00
MG
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ʤʩʥʥʺʤ
HSLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRIP\RFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWK-XYHQLOH0\RFORQLF(SLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGDVPRQRWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQSDWLHQWIURP\HDUVRIDJHZLWKQHZO\GLDJQRVHG
HSLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGLQWKHWUHDWPHQWRISULPDU\JQHUDOL]HGWRQLFFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWKLGLRSDWKLFJHQHUDOLVHGHSLOHSV\
LEVETIRACETAM 1000 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 30 TABLETS; BLISTER 60 TABLETS
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
TEVA PHARMACEUTICAL INDUST.LTD
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
PER OS
LEVETIRACETAM TEVA ® 500
03/09/2009
141-44-31957-00
MG
/HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQDGXOWVDQGFKLOGUHQIURP\HDUVRIDJHZLWK
ʤʩʥʥʺʤ
HSLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRIP\RFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWK-XYHQLOH0\RFORQLF(SLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGDVPRQRWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQSDWLHQWIURP\HDUVRIDJHZLWKQHZO\GLDJQRVHG
HSLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGLQWKHWUHDWPHQWRISULPDU\JQHUDOL]HGWRQLFFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWKLGLRSDWKLFJHQHUDOLVHGHSLOHSV\
LEVETIRACETAM 500 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 30 TABLETS; BLISTER 60 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
LEVETIRACETAM TEVA ® 250
03/09/2009
141-43-31958-00
MG
/HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQDGXOWVDQGFKLOGUHQIURP\HDUVRIDJHZLWK
ʤʩʥʥʺʤ
HSLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRIP\RFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWK-XYHQLOH0\RFORQLF(SLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGDVPRQRWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQSDWLHQWIURP\HDUVRIDJHZLWKQHZO\GLDJQRVHG
HSLOHSV\
/HYHWLUDFHWDPLVLQGLFDWHGLQWKHWUHDWPHQWRISULPDU\JQHUDOL]HGWRQLFFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWKLGLRSDWKLFJHQHUDOLVHGHSLOHSV\
LEVETIRACETAM 250 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 30 TABLETS; BLISTER 60 TABLETS
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD
UNIPHARM LTD
PER OS
LERCAPRESS 10
14/09/2009
Hypertension. Mild to moderate essential hypertension.
LERCANIDIPINE HYDROCHLORIDE 10 MG
BLISTER PVC/ALUMINIUM 5 TABLETS; BLISTER PVC/ALUMINIUM 7 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS;
BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS
DEXCEL LTD
DEXCEL PHARMA TECHNOLOGIES LTD
PER OS
LOSARDEX PLUS
16/09/2009
141-51-31848-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-56-31892-00
Losardex plus is indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hypertension and ʤʩʥʥʺʤ
left ventricular hypertrophy.
HYDROCHLOROTHIAZIDE 12.5 MG ; LOSARTAN POTASSIUM 50 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/PE/PVDC/AL 2 TABLETS; BLISTER PVC/PE/PVDC/AL 10 TABLETS; BLISTER PVC/PE/PVDC/AL 14 TABLETS; BLISTER PVC/PE/PVDC/AL 20 TABLETS;
BLISTER PVC/PE/PVDC/AL 28 TABLETS; BLISTER PVC/PE/PVDC/AL 30 TABLETS
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
RECKITT BENCKISER HEALTHCARE (UK)
RECKITT BENCKISER (NEAR EAST) LTD
PER OS
GAVISCON FORTE PEPPERMINT 16/09/2009
LIMITED
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn, indigestion occurring due to the reflux of stomach contents for instance, after gastric
surgery, as a result of hiatus hernia, during pregnancy or accompanying reflux oesophagitis.
ALGINIC ACID AS SODIUM 100 MG/ML ; POTASSIUM HYDROGENCARBONATE 20 MG/ML
BOTTLE AMBER GLASS III 150 ML; BOTTLE AMBER GLASS III 250 ML; BOTTLE AMBER GLASS III 300 ML; BOTTLE AMBER GLASS III 500 ML
ʸʩʹʫʺʸʴʱʮ
141-57-31835-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
RECKITT BENCKISER HEALTHCARE (UK)
RECKITT BENCKISER (NEAR EAST) LTD
PER OS
GAVISCON PEPPERMINT
16/09/2009
141-58-31757-00
LIMITED
TABLETS
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgatation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in ʤʩʥʥʺʤ
patients with symptoms related to reflux oesophagitis.
CALCIUM CARBONATE 80 MG ; SODIUM BICARBONATE 133.5 MG ; ALGINIC ACID AS SODIUM 250 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/PE/PVDC/AL 64 TABLETS; BLISTER PVC/PE/PVDC/AL 4 TABLETS; BLISTER PVC/PE/PVDC/AL 6 TABLETS; BLISTER PVC/PE/PVDC/AL 8 TABLETS;
BLISTER PVC/PE/PVDC/AL 16 TABLETS; BLISTER PVC/PE/PVDC/AL 24 TABLETS; BLISTER PVC/PE/PVDC/AL 32 TABLETS; BLISTER PVC/PE/PVDC/AL 48 TABLETS
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD
PER OS
ESTO 10
17/09/2009
Treatment of depression and panic disorder. Treatment of generalized anxiety disorder (GAD), treatment of social anxiety disorder (social phobia).
ESCITALOPRAM AS OXALATE 10 MG
BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 20 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD
PER OS
ESTO 20
17/09/2009
Treatment of depression and panic disorder. Treatment of generalized anxiety disorder (GAD) treatment of social anxiety disorder (social phobia). Treatment of obsessive compulsive disorder.
ESCITALOPRAM AS OXALATE 20 MG
BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 20 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS
SMITHKLINE BEECHAM PLC, UK
GLAXO SMITH KLINE (ISRAEL) LTD
PER OS
REQUIP MODUTAB 2 MG
17/09/2009
ʺʥʦʩʸʠ
141-60-31712-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-61-31970-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-62-31838-00
Ropinirole is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. As adjunctive treatment to L-dopa, ʤʩʥʥʺʤ
ropinirole enhances the efficacy of L-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic L-dopa therapy and permits reduction in daily Ldopa dose.
ROPINIROLE AS HYDROCHLORIDE 2 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 28 TABLETS; BLISTER 84 TABLETS
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
SMITHKLINE BEECHAM PLC, UK
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
GLAXO SMITH KLINE (ISRAEL) LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
REQUIP MODUTAB 4 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
17/09/2009
141-64-31839-00
Ropinirole is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. As adjunctive treatment to L-dopa, ʤʩʥʥʺʤ
ropinirole enhances the efficacy of L-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic L-dopa therapy and permits reduction in daily Ldopa dose.
ROPINIROLE AS HYDROCHLORIDE 4 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 28 TABLETS; BLISTER 84 TABLETS
SMITHKLINE BEECHAM PLC, UK
GLAXO SMITH KLINE (ISRAEL) LTD
PER OS
REQUIP MODUTAB 8 MG
17/09/2009
141-63-31840-00
Ropinirole is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. As adjunctive treatment to L-dopa, ʤʩʥʥʺʤ
ropinirole enhances the efficacy of L-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic L-dopa therapy and permits reduction in daily Ldopa dose.
ROPINIROLE AS HYDROCHLORIDE 8 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER 28 TABLETS; BLISTER 84 TABLETS
B.BRAUN MELSUNGEN AG, GERMANY
LUXEMBURG PHARMACEUTICALS LTD
I.V
PROPOFOL LIPURO 2 %
29/09/2009
141-66-31763-00
Propofol is a short-acting intravenous anesthetic agent suitable for induction and maintenance of general anesthesia in adults. Propofol may also be used for sedation of ventilated ʤʩʥʥʺʤ
adult patients receiving intensive care .for surgical procedures which do not exceed one hour in duration. Propofol may also be used for conscious sedation for surgical and
diagnostic procedures.
PROPOFOL 20MG/ML
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE GLASS 50 ML
SANOFI - AVENTIS S.P.A., ITALY
SANOFI - AVENTIS ISRAEL LTD
PER OS
AMARYL 4 MG
01/10/2009
Non-insulin-dependent diabetes melitus ( adult-onset diabetes, type II diabetes), when diet, regular physical exercise, and weight reduction alone cannot maintain therapeutically
suitable blood glucose levels.
GLIMEPIRIDE 4 MG
BLISTER PVC/ALUMINIUM 120 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 60 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 120 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 30
TABLETS; BLISTER PVC/ALUMINIUM 60 TABLETS
RECKITT & BENCKISER HEALTHCARE (UK) LTD RECKITT BENCKISER (NEAR EAST) LTD
PER OS
GAVISCON LIQUID PEPPERMINT 01/10/2009
Gastro reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric
reflux.
ALGINIC ACID AS SODIUM 50MG/ML ; SODIUM BICARBONATE 26.7MG/ML ; CALCIUM CARBONATE 16MG/ML
BOTTLE AMBER GLASS 600 ML; BOTTLE AMBER GLASS 150 ML; BOTTLE AMBER GLASS 200 ML; BOTTLE AMBER GLASS 300 ML
ʪʥʺʮʣʥʮʲ
141-68-31917-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-67-31756-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
SANDOZ GmbH, AUSTRIA
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
MASROUJI COMPANY LTD
ʯʥʰʩʮʺʸʥʶ
I.V; I.M
ʸʩʹʫʺʭʹ
CEFAZOLIN SANDOZ 0.5 G
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
01/10/2009
141-69-31812-00
Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis. Treatment Respiratory tract: Respiratory tract infections due to
ʤʩʥʥʺʤ
streptococcus pneumoniae (formerly diplococcus pneumoniae) klebsiella species haemophilus influenzae staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and
group A B - hemolytic streptococci. Cefazolin is effective in the eradication of streptococci from the nasopharynx. However data establishing the efficacy of cefazolin in the
subsequent prevention of rheumatic fever are not available at present. Urinary tract: Infections due to escherichia coli klebsiella species proteus mirabilis and some strains of
Enterobacter and enterococci. Skin and skin structure: -hemolytic beta Infections due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A streptococci
and other strains of streptococci. Biliary tract: Infections due to escherichia coli various strains of streptococci proteus mirabilis klebsiella species and staphylococcus aureus.
Bone and joint : Infections due to staphylococcus aureus. Genital infections (i.e. prostatitis epididymitis) due to escherichia coli proteus mirabilis klebsiella species and some
strains of enterococci. Septicemia due to streptococcus pneumoniae (formerly diplococcus pneumoniae) staphylococcus aureus (penicillin-sensitive and penicillin-resistant)
proteus mirabilis escherichia coli and klebsiella species. Endocarditis caused by staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic
streptococci. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin. Perioperative prophylaxis:
The prophylactic administraton of cefazolin perioperatively (preoperatively intraoperatively and postoperatively) may reduce the incidence of certain postoperative infectons in
patients undergoing surgical procedures (e.g. hysterectomy gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated.
The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and
prosthetic arthroplasty).
CEFAZOLIN AS SODIUM 500MG/VIAL
ʭʩʡʩʫʸʮ
VIAL GLASS TYPE III 100 x 15 ML; VIAL GLASS TYPE III 1 x 15 ML; VIAL GLASS TYPE III 5 x 15 ML; VIAL GLASS TYPE III 10 x 15 ML; VIAL GLASS TYPE III 25 x 15 ML;
VIAL GLASS TYPE III 50 x 15 ML
SANDOZ GmbH, AUSTRIA
MASROUJI COMPANY LTD
I.V; I.M
CEFAZOLIN SANDOZ 1 G.
01/10/2009
ʺʥʦʩʸʠ
141-70-31813-00
Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis. Treatment Respiratory tract: Respiratory tract infections due to
ʤʩʥʥʺʤ
streptococcus pneumoniae (formerly diplococcus pneumoniae) klebsiella species haemophilus influenzae staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and
group A B - hemolytic streptococci. Cefazolin is effective in the eradication of streptococci from the nasopharynx. However data establishing the efficacy of cefazolin in the
subsequent prevention of rheumatic fever are not available at present. Urinary tract: Infections due to escherichia coli klebsiella species proteus mirabilis and some strains of
Enterobacter and enterococci. Skin and skin structure: -hemolytic beta Infections due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A streptococci
and other strains of streptococci. Biliary tract: Infections due to escherichia coli various strains of streptococci proteus mirabilis klebsiella species and staphylococcus aureus.
Bone and joint : Infections due to staphylococcus aureus. Genital infections (i.e. prostatitis epididymitis) due to escherichia coli proteus mirabilis klebsiella species and some
strains of enterococci. Septicemia due to streptococcus pneumoniae (formerly diplococcus pneumoniae) staphylococcus aureus (penicillin-sensitive and penicillin-resistant)
proteus mirabilis escherichia coli and klebsiella species. Endocarditis caused by staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic
streptococci. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin. Perioperative prophylaxis:
The prophylactic administraton of cefazolin perioperatively (preoperatively intraoperatively and postoperatively) may reduce the incidence of certain postoperative infectons in
patients undergoing surgical procedures (e.g. hysterectomy gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated.
The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and
prosthetic arthroplasty).
CEFAZOLIN AS SODIUM 1G/VIAL
ʭʩʡʩʫʸʮ
VIAL GLASS TYPE III 100 x 15 ML; VIAL GLASS TYPE III 1 x 15 ML; VIAL GLASS TYPE III 5 x 15 ML; VIAL GLASS TYPE III 10 x 15 ML; VIAL GLASS TYPE III 25 x 15 ML;
VIAL GLASS TYPE III 50 x 15 ML
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʯʸʶʩ
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ORTHO - McNEIL PHARMACEUTICAL INC, USA J-C HEALTH CARE LTD
I.V
ʸʩʹʫʺʭʹ
DORIBAX
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
01/10/2009
141-65-31870-00
'RULED[LVLQGLFDWHGIRUWKHWUHDWPHQWRIWKHIROORZLQJLQIHFWLRQVLQDGXOWV
&RPSOLFDWHGLQWUDDEGRPLQDOLQIHFWLRQV
&RPSOLFDWHGXULQDU\WUDFWLQIHFWLRQV
&RQVLGHUDWLRQVKRXOGEHJLYHQWRRIILFLDOJXLGDQFHRQWKHDSSURSULDWHXVHRIDQWLEDFWHULDODJHQWV
DORIPENEM 500 MG
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 10 VIALS
PERRIGO COMPANY, USA
PERRIGO ISRAEL AGENCIES LTD
NAIL
MYCONAIL
01/10/2009
For the treatment of fungal infections of the nails.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
CICLOPIROX 80MG/G
BOTTLE GLASS TYPE III 6.6 ML
MERCK & CO., INC.,USA
MERCK SHARP & DOHME ISRAEL LTD
PER OS
TREDAPTIVE 1000 MG/ 20 MG
20/10/2009
Tredaptive is indicated for the treatment of dyslipidaemia particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL- cholesterol and
triglycerides and low HDL-cholesterol ) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in
combination with HMG-CoA reductase inhibitors (statins) when the cholesterol lowering effect of HMG-Coa reductase inhibitor monotherapy is inadequate. It can be used as
monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet and oter non-pharmacological treatments (e.g. exercise
weight reduction) should be continued during therapy with Tredaptive.
NICOTINIC ACID 1000 MG ; LAROPIPRANT 20 MG
BLISTER ACLAR/ALUMINIUM 14 CAPSULES; BLISTER ACLAR/ALUMINIUM 28 CAPSULES; BLISTER ACLAR/ALUMINIUM 56 CAPSULES
MERCK & CO., INC.,USA
MERCK SHARP & DOHME ISRAEL LTD
PER OS
TREDAPTIVE 1000 MG/ 20 MG
20/10/2009
Tredaptive is indicated for the treatment of dyslipidaemia particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL- cholesterol and
triglycerides and low HDL-cholesterol ) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in
combination with HMG-CoA reductase inhibitors (statins) when the cholesterol lowering effect of HMG-Coa reductase inhibitor monotherapy is inadequate. It can be used as
monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet and oter non-pharmacological treatments (e.g. exercise
weight reduction) should be continued during therapy with Tredaptive.
NICOTINIC ACID 1000 MG ; LAROPIPRANT 20 MG
BLISTER ACLAR/ALUMINIUM 14 CAPSULES; BLISTER ACLAR/ALUMINIUM 28 CAPSULES; BLISTER ACLAR/ALUMINIUM 56 CAPSULES
DEXXON LTD
141-71-31856-00
DEXXON LTD
PER OS
Contraceptive.
GESTODENE 0.075 MG ; ETHINYLESTRADIOL 0.03 MG
BLISTER PVC/PVDC/ALUMINIUM 3 x 21 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 21 TABLETS
ʪʥʺʮʣʥʮʲ
YAEL
20/10/2009
141-73-31893-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-74-31893-11
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-75-32997-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
GLAXO GROUP LIMITED, UK
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
GLAXO SMITH KLINE (ISRAEL) LTD
NASAL
ʸʩʹʫʺʭʹ
AVAMYS
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
01/11/2009
141-80-31837-00
AVAMYS (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
FLUTICASONE FUROATE 27.5 MCG/DOSE
BOTTLE AMBER GLASS TYPE I 30 SINGLE DOSE; BOTTLE AMBER GLASS TYPE I 60 SINGLE DOSE; BOTTLE AMBER GLASS TYPE I 120 SINGLE DOSE
GENZYME IRELAND LTD
GENZYME ISRAEL LTD
PER OS
CHOLESTAGEL
03/11/2009
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-81-31865-00
Cholestagel co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol (LDL-C) levels ʤʩʥʥʺʤ
in patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for
teduction of elevated total and LDL- cholesterol in patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.
COLESEVELAM HYDROCHLORIDE 625 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE HDPE 180 TABLETS
NOVARTIS CONSUMER HEALTH SA,
NUTRITION CONSUMER HEALTH
PER OS
EXCEDRIN
04/11/2009
SWITZERLAND
For temporary relief of the pain of headache, mild to moderate pain associated with migraine headache, pain of menstrual descomfort and pain accompanied by fever.
PARACETAMOL 250 MG ; ACETYLSALICYLIC ACID 250 MG ; CAFFEINE 65 MG
BLISTER PVC/PCTFE/PVC 10 CAPLETS; BOTTLE HDPE 50 CAPLETS; BOTTLE HDPE 24 CAPLETS
TEVA PARENTERAL MEDICINES INC, USA
SALOMON,LEVIN & ELSTEIN LTD
I.V
EPOPROSTENOL TEVA ® 0.5 MG
05/11/2009
Epoprostenol Teva is indicated for the long-term intravenous treatment of primary arterial pulmonary hypertension and arterial pulmonary hypertension associated with the
scleroderma spectrum of disease in NYHA class III and class IV patients who do not respond to conventional therapy.
EPOPROSTENOL AS SODIUM 0.5 MG
VIAL GLASS TYPE I 2 x 50 ML; VIAL GLASS TYPE I 1 x 0.5 MG
MERCK SHARP & DOHME B.V, HOLLAND
MERCK SHARP & DOHME ISRAEL LTD
PER OS
ARCOXIA 30 MG TABLETS
10/11/2009
Arcoxia tablets are indicated for the symptomatic relief of osteoarthritis (OA).
ETORICOXIB 30 MG
BLISTER POLYAMIDE/ALUMINUM/PVC 2 TABLETS; BLISTER POLYAMIDE/ALUMINUM/PVC 7 TABLETS; BLISTER POLYAMIDE/ALUMINUM/PVC 28 TABLETS
ASTRA ZENECA UK LIMITED
ASTRA ZENECA ISRAEL LTD
PER OS
SEROQUEL XR 200 MG
15/11/2009
141-82-31782-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-84-32941-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-86-31986-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
141-90-31974-00
Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ
XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major
depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes.
ʭʩʡʩʫʸʮ
QUETIAPINE FUMARATE 200 MG
BLISTER PVC/PCTFE 100 TABLETS; BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 60 TABLETS; BLISTER PVC/PCTFE 50 ʺʥʦʩʸʠ
TABLETS
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ASTRA ZENECA UK LIMITED
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ASTRA ZENECA ISRAEL LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
SEROQUEL XR 300 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
15/11/2009
141-91-31975-00
Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ
XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major
depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes.
QUETIAPINE FUMARATE 300 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/PCTFE 100 TABLETS; BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 50 TABLETS; BLISTER PVC/PCTFE 60 ʺʥʦʩʸʠ
TABLETS
ASTRA ZENECA UK LIMITED
ASTRA ZENECA ISRAEL LTD
PER OS
SEROQUEL XR 50 MG
15/11/2009
141-89-31973-00
Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ
XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major
depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes.
ʭʩʡʩʫʸʮ
QUETIAPINE FUMARATE 50 MG
BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 50 TABLETS; BLISTER PVC/PCTFE 60 TABLETS; BLISTER PVC/PCTFE 100 ʺʥʦʩʸʠ
TABLETS
ASTRA ZENECA UK LIMITED
ASTRA ZENECA ISRAEL LTD
PER OS
SEROQUEL XR 400 MG
15/11/2009
141-92-31976-00
Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ
XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major
depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes.
QUETIAPINE FUMARATE 400 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/PCTFE 100 TABLETS; BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 50 TABLETS; BLISTER PVC/PCTFE 60 ʺʥʦʩʸʠ
TABLETS
MEDIMMUNE LLC, USA
ASTRA ZENECA ISRAEL LTD
INTRANASAL
FLUMIST
16/11/2009
141-88-32988-00
FluMist is a vaccine indicated for the active immunization of individuals 2- 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in ʤʩʥʥʺʤ
the vaccine.
B/BRISBANE/60/2008 7±0.5 log 10FFU / 0.2 ML ; A/BRISBANE/59/2007 (H1N1) 7±0.5 log 10FFU / 0.2 ML ; A/BRISBANE/10/2007 (H3N2) 7±0.5 log 10FFU / 0.2 ML
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
SPRAY UNIT DOSE GLASS TYPE I 10 DOSES
BAUSCH & LOMB INCORPORATED, USA
SALOMON,LEVIN & ELSTEIN LTD
OCULAR
LOTEMAX ®
16/11/2009
141-93-31617-00
Lotemax is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as
ʤʩʥʥʺʤ
allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is
accepted to otain an advisable diminution in edema and inflammation. Lotemax is less effective than prednisolone acetate 1 % in two 28 day controlled clinical studies in acute
anterior uveitis, where 72 % of patients treated with Lotemax experienced resolution of anterior chamber cells, compared to 87 % of patients treated with prednisolone acetate 1 % .
The incidence of patients with clinically significant increases in IOP (> or = 10 mmHg) was 1 % with Lotemax adn 6 % with prednisolone acetate 1 %. Lotemax should not be used in
patients who require a more potent corticosteroid for this indication. Lotemax is also indicated for the treatment of post - operative inflammation following ocular surgery.
LOTEPREDNOL ETABONATE 5 MG / 1 ML
ʭʩʡʩʫʸʮ
BOTTLE LPDE 1 x 15 ML; BOTTLE LPDE 1 x 2.5 ML; BOTTLE LPDE 1 x 5 ML; BOTTLE LPDE 1 x 10 ML
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ORION CORPORATION ORION
NOVARTIS PHARMA SERVICES AG
PER OS
STALEVO 200/50/200 MG
PHARMA,FINLAND
Treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
22/11/2009
141-94-31768-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
LEVODOPA 200 MG ; ENTACAPONE 200 MG ; CARBIDOPA 50 MG (AS MONOHYDRATE)
BOTTLE HDPE 10 TABLETS; BOTTLE HDPE 30 TABLETS; BOTTLE HDPE 100 TABLETS
ANBEX INC, USA
GOLDEN HEART F.M.C.G. LTD
PER OS
IOSAT
01/12/2009
Iosat (Potassium iodide tablets USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
POTASSIUM IODIDE 130 MG
STRIPS ALUMINIUM 14 TABLETS
SANOFI WINTHROP INDUSTRIE, FRANCE
SANOFI - AVENTIS ISRAEL LTD
PER OS
AMBIEN CR 6.25 MG
01/12/2009
For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
BLISTER PVC/ALUMINIUM 28 TABLETS
SANOFI - AVENTIS ISRAEL LTD
PER OS
AMBIEN CR 12.5 MG
01/12/2009
For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
BLISTER PVC/ALUMINIUM 28 TABLETS
PHARMASWISS ISRAEL LTD
PER OS
SWISS RELIEF DUAL RELEASE
142-06-31834-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ZOLPIDEM TARTRATE 12.5 MG
TEMMLER WERKE GmbH, GERMANY
142-05-31833-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ZOLPIDEM TARTRATE 6.25 MG
SANOFI WINTHROP INDUSTRIE, FRANCE
142-03-31868-00
03/12/2009
142-10-31815-00
As a non-steroidal anti-inflamatory analgesic in symptomatic management of rheumatoid arthritis osteoarthritis and ankylosying spondylitis acute musculo-skeletal disorders such ʤʩʥʥʺʤ
as periarthritis tendenitis tensynovitis bursitis sprains strains and dislocations relief of pain in fractures low back pain acute gout psoriatic arthropathy. In the management of
pain and inflammation associated with orthopaedic dental and minor surgery.
DICLOFENAC SODIUM 75 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVC/PVDC 4 CAPSULES; BLISTER PVC/PVDC 20 CAPSULES; BLISTER PVC/PVDC 56 CAPSULES
LES LABORATOIRES SERVIER INDUST.,
MEDILINE LTD.
FRANCE
Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
PER OS
PROTELOS
06/12/2009
STRONTIUM RANELATE 2 G
SACHET PAPER/PE/ALU/PE 7 ; SACHET PAPER/PE/ALU/PE 14 ; SACHET PAPER/PE/ALU/PE 28 ; SACHET PAPER/PE/ALU/PE 56 ; SACHET PAPER/PE/ALU/PE 100 ;
SACHET PAPER/PE/ALU/PE 84
ʪʥʺʮʣʥʮʲ
142-09-31882-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
BEUTLICH L.P. PHARMACEUTICALS, USA
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
LEVY DENTAL CO. LTD
ʯʥʰʩʮʺʸʥʶ
ORAL
ʸʩʹʫʺʭʹ
HURRICAINE
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
06/12/2009
142-11-32950-00
+XUULFDLQHLVGHVLJQHGIRUDQ\GHQWDOSURFHGXUHLQZKLFKWRSLFDODQHVWKHVLDLVGHVLUHG
ʤʩʥʥʺʤ
+XUULFDLQHLVDOVRXVHGIRUWHPSRUDU\UHOLHIRIRFFDVLRQDOPLQRULUULWDWLRQDQGSDLQDVVRFLDWHGZLWKFDQNHUVRUHVVRUHPRXWKDQGWKURDWPLQRULQMXU\RIWKHPRXWKDQGJXPVFDXVHG
E\GHQWXUHVRURUWKRGHQWLFDSSOLDQFHV
BENZOCAINE 20%W/W
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE HDPE 28.35 G
JANSSEN CILAG S.P.A., ITALY
J-C HEALTH CARE LTD
PER OS
PREZISTA 400 MG
10/12/2009
142-12-31999-00
Prezista , co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection
ʤʩʥʥʺʤ
for over 18 years of age.
DARUNAVIR AS ETHANOLATE 400 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE HDPE 60 TABLETS
JANSSEN CILAG S.P.A., ITALY
J-C HEALTH CARE LTD
PER OS
PREZISTA 600 MG
10/12/2009
142-13-32000-00
Prezista , co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection
ʤʩʥʥʺʤ
for over 18 years of age.
DARUNAVIR AS ETHANOLATE 600 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE HDPE 60 TABLETS
TARO PHARMACEUTICAL INDUSTRIES LTD
TARO PHARMACEUTICAL INDUSTRIES
LTD
PER OS
NORMALAX
14/12/2009
For the treatment of constipation.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
POLYETHYLENE GLYCOL 3350 100 %W/W
BOTTLE HDPE 150 ML; BOTTLE HDPE 400 ML
DR.R.PFLEGER CHEMISCHE FABRIK GmbH
TEC-O-PHARM-LIBRA LTD
PER OS
SPASMEX 30
14/12/2009
For the treatment of vegetative bladder dysfunction accompanied by urgency and/or frequency and/or urinary incontinence.
BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS
MEDICI LTD
I.M
142-14-31805-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
TROSPIUM CHLORIDE 30 MG
SANOFI PASTEUR LTD, CANADA
142-15-32012-00
ADACEL
14/12/2009
142-16-32020-00
Active booster immunization against diphtheria, tetanus and pertussis in children, adolescents and adults aged 4 to 64 years. Adacel is not indicated for treating diseases caused by ʤʩʥʥʺʤ
B.pertussis, C.diphtheriae or C. tetani infections.
PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE ; FILAMENTOUS HAEMOGGLUTININ (FHA) 5 MCG/DOSE ; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE ; PERTACTIN (PRN) ʭʩʡʩʫʸʮ
3 MCG/DOSE ; DIPHTHERIA TOXOID 2LF / 1 DOSES; TETANUS TOXOID 5LF / 1 DOSES
VIAL GLASS TYPE I 1 x 0.5 ML; VIAL GLASS TYPE I 5 x 0.5 ML
ʺʥʦʩʸʠ
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
ʸʩʹʫʺʭʹ
REPAGLINIDE TEVA ® 0.5 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
21/12/2009
142-17-32017-00
Treatment of type II diabetes.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
REPAGLINIDE 0.5 MG
BLISTER ALUMINIUM /ALUMINIUM 90 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
REPAGLINIDE TEVA ® 1 MG
21/12/2009
Treatment of type II diabetes.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
REPAGLINIDE 1 MG
BLISTER ALUMINIUM /ALUMINIUM 90 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
REPAGLINIDE TEVA ® 2 MG
21/12/2009
Treatment of type II diabetes.
142-19-32019-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
REPAGLINIDE 2 MG
BLISTER ALUMINIUM /ALUMINIUM 90 TABLETS
PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD
I.V
OXALIPLATIN PWD TEVA ®
24/12/2009
2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU
$GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH
V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU
7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU
OXALIPLATIN 50MG/VIAL
PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
I.V
OXALIPLATIN TEVA ®
31/12/2009
2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU
$GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH
V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU
7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU
OXALIPLATIN 5MG/ML
142-23-31784-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 4 ML; VIAL GLASS TYPE I 1 x 10 ML; VIAL GLASS TYPE I 1 x 20 ML; VIAL GLASS TYPE I 1 x 40 ML
TEVA PHARMACEUTICAL INDUST.LTD
142-20-31785-00
ʤʩʥʥʺʤ
VIAL GLASS TYPE I 1 x 50 MG
TEVA PHARMACEUTICAL INDUSTRIES LTD
142-18-32018-00
OCULAR
For the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
BRIMONIDINE TARTRATE 0.15%W/V
BOTTLE LDPE 5 ML
ʪʥʺʮʣʥʮʲ
BRIMONIDINE TEVA ®
31/12/2009
142-22-31742-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʯʸʶʩ
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
HOFFMANN LA ROCHE LTD, SWITZERLAND
ROCHE PHARMACEUTICAL (ISRAEL)
I.V
ACTEMRA 20MG/ML
01/01/2010
142-21-31931-00
LTD
Actemra (tocilizumab) is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one ʤʩʥʥʺʤ
or more DMARDs (Disease modifying antirhematic drugs) or TNF antagonists or in whom DMARDs cannot be used. Actemra can be used alone or in combination with methotrexate
or other DMARDs.
TOCILIZUMAB 20 MG/ML
ʭʩʡʩʫʸʮ
VIAL GLASS TYPE I 1 x 4 ML; VIAL GLASS TYPE I 4 x 4 ML; VIAL GLASS TYPE I 1 x 10 ML; VIAL GLASS TYPE I 4 x 10 ML; VIAL GLASS TYPE I 1 x 20 ML; VIAL GLASS
TYPE I 4 x 20 ML
N.V. ORGANON, NETHERLANDS
SCHERING PLOUGH ISRAEL AG
I.V
BRIDION
06/01/2010
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
VIAL GLASS TYPE I 10 x 2 ML; VIAL GLASS TYPE I 10 x 5 ML
TEVA PHARMACEUTICAL INDUST.LTD
142-27-31898-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
SUGAMMADEX 100 MG/ML
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʦʩʸʠ
PER OS
ETODOLAC ER TEVA ® 400 MG
06/01/2010
142-24-31718-00
For the management of signs and symptoms of osteoarthritis and rehumatoid arthritis.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 14 TABLETS; BLISTER PVDC/ALUMINIUM 20 TABLETS; ʺʥʦʩʸʠ
ETODOLAC 400 MG
BLISTER PVDC/ALUMINIUM 21 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
ETODOLAC ER TEVA ® 600 MG
06/01/2010
142-26-31720-00
For the management of signs and symptoms of osteoarthritis and rehumatoid arthritis.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 14 TABLETS; BLISTER PVDC/ALUMINIUM 20 TABLETS; ʺʥʦʩʸʠ
ETODOLAC 600 MG
BLISTER PVDC/ALUMINIUM 21 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
For the management of signs and symptoms of osteoarthritis and rehumatoid arthritis.
ETODOLAC ER TEVA ® 500 MG
06/01/2010
142-25-31719-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 14 TABLETS; BLISTER PVDC/ALUMINIUM 20 TABLETS; ʺʥʦʩʸʠ
ETODOLAC 500 MG
BLISTER PVDC/ALUMINIUM 21 TABLETS
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
ʸʩʹʫʺʭʹ
LETROZOLE TEVA ®
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
06/01/2010
142-28-31878-00
Letrozole teva tablets is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whom hormone receptor status cannot be determined,
locally advanced or metastatic breast cancer: Letrozole teva is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression
following antiestrogen therapy. Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy.
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
LETROZOLE 2.5 MG
BLISTER PVDC/ALUMINIUM 28 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS
CHEMIPHARMA S.P.A., ITALY
ROMAT LTD, RAMAT-GAN
PER OS IN DRINKING
TAF 25 % VETERINARY
10/01/2010
WATER
For the treatment of bacterial diseases of the respiratory and intestinal system, caused especially by Gram-positive and Gram-negative micro-organisms, mycoplasmas and
clamydiae in broilers.
THIAMPHENICOL 250MG/ML
BOTTLE POLYETHYLENE 1000 ML; CAN POLYETHYLENE 5000 ML
CHATTEM GLOBAL CONSUMER PRODUCTS
LTD
Treatment of dandruff and seborrhoea capitis.
MEDILINE LTD.
TOPICAL
SELSUN SHAMPOO 2.5 % W/V
10/01/2010
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-30-92419-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-29-32028-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
SELENIUM SULFIDE 25 MG/ML
BOTTLE PEHD 150 ML; BOTTLE PEHD 50 ML; BOTTLE PEHD 100 ML
WEST PHARMA- PROD. DE ESPEC.
BIOAVENIR LTD
PER OS
LETROZOLE FARMOZ
10/01/2010
142-31-31918-00
FARMACEUT.S.A.
Letrozole Farmoz tablets is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whom hormone receptor status cannot be determined, ʤʩʥʥʺʤ
locally advanced or metastatic breast cancer: Letrozole Farmoz is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression
following antiestrogen therapy. Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy.
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
LETROZOLE 2.5 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER ALUMINIUM 30 TABLETS
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
For the treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence.
TOLTERODINE TARTRATE 2 MG
BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BLISTER PVDC/ALUMINIUM 30 CAPSULES
ʪʥʺʮʣʥʮʲ
TOLTERODINE E.R. TEVA ® 2 MG 12/01/2010
142-32-31790-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
TOLTERODINE E.R. TEVA ® 4 MG 12/01/2010
For the treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence.
BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BLISTER PVDC/ALUMINIUM 30 CAPSULES
J-C HEALTH CARE LTD
S.C
STELARA 45 MG
13/01/2010
STELARA™ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to,or have contraindication to or who are
intolerant to other systemic therapies including ciclosporin,methotrexate and psoralen plus U.V (PUVA).
USTEKINUMAB 45 MG / 0.5 ML
VIAL GLASS 1 x 0.5 ML
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
142-33-31791-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
TOLTERODINE TARTRATE 4 MG
CILAG AG, SWITZERLAND
ʸʩʹʫʺʸʴʱʮ
PER OS
MYCOPHENOLATE TEVA ® 500
13/01/2010
MG
Prophylaxis of rejection in renal allograft recepients, in patients receiving allogenic cardiac transplants and in allogenic hepatic transplants. Mycophenolate Teva should be used
concomitantly with ciclosporin and corticosteroids.
MYCOPHENOLATE MOFETIL 500 MG
142-36-32021-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-37-32978-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
BLISTER PVDC/ALUMINIUM 60 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 50 TABLETS ʺʥʦʩʸʠ
BAYER ANIMAL HEALTH GmbH, GERMANY
LIDORR CHEMICALS LTD
DERMAL
ADVOCATE FOR DOGS
13/01/2010
142-38-92431-00
VETERINARY
For dogs suffering from or at risk from mixed parasitic infections : For the treatment and prevention of flea infestation (Ctenocephalides felis) treatment of biting lice (Trichodectes ʤʩʥʥʺʤ
canis) treatment of ear mit infestation (Otodectes cynotis) sarcoptic mange (caused by sarcoptes scabiei var. canys) demodicosis ( caused by demodex canis) prevention of
heartworm disease (L3 and L4 larvae of dirofilaria immitis) treatment of angiostrongylus vasorum adn treatment of infections with gastrointestinal nematodes (L4 larve immature
adults and adults of toxocara canis ancylostoma caninum and uncinaria stenocephala adults of toxascaris leonina and trichuris vulpis). The product can be used as part of a
treatment strategy for flea allergy dermatitis (FAD).
ʭʩʡʩʫʸʮ
IMIDACLOPRID 100 MG/ML ; MOXIDECTIN 25 MG/ML
TUBE POLYPROPYLENE 6 x 0.4 ML; TUBE POLYPROPYLENE 3 x 2.5 ML; TUBE POLYPROPYLENE 3 x 4 ML; TUBE POLYPROPYLENE 6 x 4 ML; TUBE POLYPROPYLENE ʺʥʦʩʸʠ
6 x 2.5 ML; TUBE POLYPROPYLENE 3 x 1 ML; TUBE POLYPROPYLENE 6 x 1 ML; TUBE POLYPROPYLENE 3 x 0.4 ML
BAYER ANIMAL HEALTH GmbH, GERMANY
LIDORR CHEMICALS LTD
DERMAL
ADVOCATE FOR CATS
13/01/2010
142-39-92432-00
VETERINARY
For cats suffering from or at risk from mixed parasitic infections : For the treatment and prevention of flea infestation (Ctenocephalides felis) treatment of ear mit infestation
ʤʩʥʥʺʤ
(Otodectes cynotis) prevention of heartworm disease (L3 and L4 larvae of dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larve immature adults
and adults of toxocara cati ancylostoma tubaeforne). The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
IMIDACLOPRID 100 MG/ML ; MOXIDECTIN 10 MG/ML
ʭʩʡʩʫʸʮ
TUBE POLYPROPYLENE 3 x 0.8 ML; TUBE POLYPROPYLENE 6 x 0.4 ML; TUBE POLYPROPYLENE 6 x 0.8 ML; TUBE POLYPROPYLENE 3 x 0.4 ML
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʯʸʶʩ
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD
I.V
ʸʩʹʫʺʭʹ
OXALIPLATIN PWD TEVA ®
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
14/01/2010
142-34-33148-00
2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU
$GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH
V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU
7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU
OXALIPLATIN 20MG/VIAL
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 20 MG
PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD
I.V
OXALIPLATIN PWD TEVA ®
14/01/2010
2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU
$GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH
V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU
7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU
OXALIPLATIN 100MG/VIAL
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 100 MG
SAM-ON LTD., BAT-YAM
SAM-ON LTD
PER OS
FOLEX 400 NEW
19/01/2010
For the prevention and treatment of iron deficiency anemia and for maintaining the level of folic acid particular in pregnancy.
FOLIC ACID 400 MCG ; FERROUS FUMARATE 100 MG
BLISTER PVC/ALUMINIUM 1000 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS;
BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 90 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS
NOVARTIS PHARMA SCHWEIZ AG.,
NUTRITION CONSUMER HEALTH
TOPICAL
FENLIPS
20/01/2010
SWITZERLAND
For the topical treatment for cold sores (oral herpes).
PENCICLOVIR 10MG/G
TUBE ALUMINIUM 2 G; TUBE ALUMINIUM 2 G
H.LUNDBECK A/S, DENMARK
LUNDBECK ISRAEL LTD
142-35-33149-00
PER OS
CIPRAMIL 40 MG TABLETS
21/01/2010
For the treatment of states of depresion and panic disorder.
Antipyretic, analgesic.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-41-31798-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-50-32025-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
CITALOPRAM AS HYDROBROMIDE 40 MG
BLISTER PVC/PVDC/ALUMINIUM 98 TABLETS; CONTAINER POLYPROPYLENE 100 TABLETS; CONTAINER POLYPROPYLENE 250 TABLETS; BLISTER
PVC/PVDC/ALUMINIUM 14 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 56 TABLETS
PERRIGO COMPANY, USA
PERRIGO ISRAEL AGENCIES LTD
PER OS
MACCABIMOL KID DROPS
142-40-33082-00
21/01/2010
142-51-33085-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
PARACETAMOL 80 MG / 0.8 ML
DROPER BOTTLE POLYETHYLENE 30 ML
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
LES LABORATOIRES SERVIER INDUST.,
MEDILINE LTD.
PER OS
CORALAN 5 MG
FRANCE
Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
21/01/2010
142-49-32001-00
IVABRADINE AS HYDROCHLORIDE 5 MG
BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 56 TABLETS; BLISTER PVC/ALUMINIUM 84 TABLETS;
BLISTER PVC/ALUMINIUM 98 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS; BLISTER PVC/ALUMINIUM 112 TABLETS
LES LABORATOIRES SERVIER INDUST.,
MEDILINE LTD.
PER OS
CORALAN 7.5 MG
21/01/2010
FRANCE
Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.
IVABRADINE AS HYDROCHLORIDE 7.5 MG
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-48-32002-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVC/ALUMINIUM 112 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 56 TABLETS;
BLISTER PVC/ALUMINIUM 84 TABLETS; BLISTER PVC/ALUMINIUM 98 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS
DOPHARMA B.V., NETHERLANDS
M.P.VET LTD
PER OS IN DRINKING
DOXYCYCLINE 50 % WSP
21/01/2010
142-47-92426-00
WATER
VETERINARY
For the treatment of infections diseases caused by bacteria sensitive to Doxycycline in broilers. Respiratory infections caused by the following microorganisms : mycoplasma spp.,
ʤʩʥʥʺʤ
e.coli and haemophilus paragallinarum, enteritis caused by clostridium spp. and clostridium colinum.
DOXYCYCLINE AS HYCLATE 50%
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
SECURITAINER POLYPROPYLENE 1 KG
UNICHEM LABORATORIES LIMITED, INDIA
ABIC MARKETING LTD
PER OS
ALFUZOSIN ER TEVA ® 10 MG
21/01/2010
Treatment of certain functional symptoms of benign prostatic hypertrophy particularly if surgery has to be delayed for some reason. Adjuvant treatment to a catheter in acute
urinary retention related to benign prostatic hypertrophy.
ALFUZOSIN HYDROCHLORIDE 10 MG
BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS
IVAX PHARMACEUTICALS UK ( TEVA
SALOMON,LEVIN & ELSTEIN LTD
RUNCORN)
Bronchial asthma especially in cases where other therapy is insufficient or insuitable.
INHALATION
BUDESONIDE STERINEBS TEVA
® 0.5 MG/2 ML
28/01/2010
BUDESONIDE 0.25 MG / 1 ML
AMPOULES POLYETHYLENE 35 x 2 ML; AMPOULES POLYETHYLENE 40 x 2 ML; AMPOULES POLYETHYLENE 45 x 2 ML; AMPOULES POLYETHYLENE 50 x 2 ML;
AMPOULES POLYETHYLENE 5 x 2 ML; AMPOULES POLYETHYLENE 10 x 2 ML; AMPOULES POLYETHYLENE 15 x 2 ML; AMPOULES POLYETHYLENE 20 x 2 ML;
AMPOULES POLYETHYLENE 25 x 2 ML; AMPOULES POLYETHYLENE 30 x 2 ML
ʪʥʺʮʣʥʮʲ
142-46-31943-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-43-33002-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
HOSPIRA AUSTRALIA PTY LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
NOVAPHARMA LTD
I.V
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
OXALIPLATIN HOSPIRA 5 MG/ML 28/01/2010
- 100 MG
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WUHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU
OXALIPLATIN 100MG/VIAL
NOVAPHARMA LTD
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
I.V
OXALIPLATIN HOSPIRA 5 MG/ML 28/01/2010
- 50 MG
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DGMXYDQWWUHDWPHQWRIVWDJH,,,'XNH
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WUHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU
OXALIPLATIN 50MG/VIAL
SANOFI - AVENTIS ISRAEL LTD
142-44-31644-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 50 MG
SANOFI WINTHROP INDUSTRIE, FRANCE
142-45-31645-00
ʤʩʥʥʺʤ
VIAL GLASS TYPE I 1 x 100 MG
HOSPIRA AUSTRALIA PTY LTD
ʸʩʹʫʺʸʴʱʮ
PER OS
MULTAQ
28/01/2010
To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent artrial fibrillation (AF) or atrial flutter ( AFL ) , with a recent episode of AF/AFL and
associated cardiovascular risk factors (i.e. age > 70, hypertension, diabetes , prior cerebrovascular accident, left atrial diameter > or = 50 mm or left ventricular ejection fraction
[ LVEF] < 40 % ), who are in sinus rhythm or who will be cardioverted.
DRONEDARONE 400 MG
142-42-32977-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS;
BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 50 TABLETS
WYETH GRANGE CASTLE (WGC), IRELAND
NEOPHARM LTD
I.V
ENBREL 25 MG PRE-FILLED
01/02/2010
142-52-31949-00
SYRINGE
Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless
ʤʩʥʥʺʤ
contraindicated) has been inadequate. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs
and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. Enbrel is indicated for the treatment of active
polyarticular-course juvenile chronic arthritis in chilldren aged 4 to 17 years who have had an inadequate response to or who have proved intolerant of methotrexate. Enbrel has
not been studied in children aged less than 4 years. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic
drug therapy has been inadequate. Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Treatment of
adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ETANERCEPT 25 MG/DOSE
ʭʩʡʩʫʸʮ
SYRINGE PREFILLED GLASS TYPE I 24 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 4 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 8 x 0.5 ML
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
WYETH GRANGE CASTLE (WGC), IRELAND
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
NEOPHARM LTD
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
I.V
ENBREL 50 MG PRE-FILLED
01/02/2010
142-53-31950-00
SYRINGE
Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless
ʤʩʥʥʺʤ
contraindicated) has been inadequate. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs
and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. Enbrel is indicated for the treatment of active
polyarticular-course juvenile chronic arthritis in chilldren aged 4 to 17 years who have had an inadequate response to or who have proved intolerant of methotrexate. Enbrel has
not been studied in children aged less than 4 years. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic
drug therapy has been inadequate. Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Treatment of
adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ETANERCEPT 50 MG/DOSE
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
SYRINGE PREFILLED GLASS TYPE I 12 x 1 ML; SYRINGE PREFILLED GLASS TYPE I 2 x 1 ML; SYRINGE PREFILLED GLASS TYPE I 4 x 1 ML
LILLY S.A., SPAIN
ELI LILLY ISRAEL LTD
PER OS
EFFIENT 10 MG
03/02/2010
142-56-32011-00
(IILHQWFRDGPLQLVWHUHGZLWKDFHW\OVDOLF\OLFDFLG$6$LVLQGLFDWHGIRUWKHSUHYHQWLRQRIDWKHURWKURPERWLFHYHQWVLQSDWLHQWVZLWKDFXWHFRURQDU\V\QGURPHLHXQVWDEOHDQJLQDQRQ ʤʩʥʥʺʤ
67VHJPHQWHOHYDWLRQP\RFDUGLDOLQIDUFWLRQ>8$167(0,@RU67VHJPHQWHOHYDWLRQP\RFDUGLDOLQIDUFWLRQ>67(0,@XQGHUJRLQJSULPDU\RUGHOD\HGSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQ
3&,
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LQWKRVHZKRKDG7,$&9$LQWKHSDVWDQGLQWKRVHDERYHWKHDJHRIDQGDZHLJKWEHORZNJ
PRASUGREL AS HYDROCHLORIDE 10 MG
BLISTER COLD FORM FOIL (CFF) 56 TABLETS; BLISTER COLD FORM FOIL (CFF) 14 TABLETS; BLISTER COLD FORM FOIL (CFF) 6 TABLETS; BLISTER COLD FORM
FOIL (CFF) 28 TABLETS; BLISTER COLD FORM FOIL (CFF) 30 TABLETS
LILLY S.A., SPAIN
ELI LILLY ISRAEL LTD
PER OS
EFFIENT 5 MG
03/02/2010
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-55-32010-00
(IILHQWFRDGPLQLVWHUHGZLWKDFHW\OVDOLF\OLFDFLG$6$LVLQGLFDWHGIRUWKHSUHYHQWLRQRIDWKHURWKURPERWLFHYHQWVLQSDWLHQWVZLWKDFXWHFRURQDU\V\QGURPHLHXQVWDEOHDQJLQDQRQ ʤʩʥʥʺʤ
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7KHLQFUHDVHGHIILFDF\VKRXOGEHEDODQFHGZLWKWKHLQFUHDVHGULVNLQSDWLHQWVZLWKEOHHGLQJWHQGHQF\
LQWKRVHZKRKDG7,$&9$LQWKHSDVWDQGLQWKRVHDERYHWKHDJHRIDQGDZHLJKWEHORZNJ
PRASUGREL AS HYDROCHLORIDE 5 MG
ʭʩʡʩʫʸʮ
BLISTER COLD FORM FOIL (CFF) 6 TABLETS; BLISTER COLD FORM FOIL (CFF) 14 TABLETS; BLISTER COLD FORM FOIL (CFF) 28 TABLETS; BLISTER COLD FORM
FOIL (CFF) 30 TABLETS; BLISTER COLD FORM FOIL (CFF) 56 TABLETS
GENZYME CORPORATION, USA
GENZYME ISRAEL LTD
S.C
MOZOBIL
03/02/2010
Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous
transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
PLERIXAFOR 20 MG ML
VIAL GLASS TYPE I 1 x 2 ML
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
142-58-32938-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
BAYER SCHERING PHARMA AG, GERMANY
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
BAYER ISRAEL LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
XARELTO 10 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
03/02/2010
142-57-31927-00
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
RIVAROXABAN 10 MG
BLISTER PVC/PVDC/ALUMINIUM 5 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 10 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER
PVC/PVDC/ALUMINIUM 100 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 5 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 10 TABLETS; BLISTER
POLYPROPYLENE/ALUMINIUM 30 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 100 TABLETS
BAUSCH & LOMB INCORPORATED, USA
SALOMON,LEVIN & ELSTEIN LTD
OCULAR
ZYLET
03/02/2010
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-61-31618-00
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ʤʩʥʥʺʤ
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DHURJHQHV3URWHXVPLUDELOLV0RUJDQHOODPRUJDQLLPRVW3URWHXVYXOJDULVVWUDLQV+DHPRSKLOXVLQIOXHQ]DHDQG+DHJ\SWLXV0RUD[HOODODFXQDWD$FLQHWREDFWHUFDOFRDFHWLFXVDQG
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TOBRAMYCIN 3MG/ML ; LOTEPREDNOL ETABONATE 5MG/ML
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BOTTLE LDPE 1 x 10 ML; BOTTLE LDPE 1 x 2.5 ML; BOTTLE LDPE 1 x 5 ML
H.LUNDBECK A/S, DENMARK
LUNDBECK ISRAEL LTD
PER OS
EBIXA TABLETS 20 MG
03/02/2010
Treatment of patient with moderate to severe Alzheimer's disease.
MEMANTINE HYDROCHLORIDE 20 MG
BLISTER PVC/PE/PVDC/AL 840 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 14 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 28 TABLETS; BLISTER
POLYPROPYLENE/ALUMINIUM 42 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 49 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 56 TABLETS; BLISTER
POLYPROPYLENE/ALUMINIUM 70 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 84 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 98 TABLETS; BLISTER
POLYPROPYLENE/ALUMINIUM 100 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 112 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 840 TABLETS; BLISTER
PVC/PE/PVDC/AL 14 TABLETS; BLISTER PVC/PE/PVDC/AL 28 TABLETS; BLISTER PVC/PE/PVDC/AL 42 TABLETS; BLISTER PVC/PE/PVDC/AL 49 TABLETS; BLISTER
PVC/PE/PVDC/AL 56 TABLETS; BLISTER PVC/PE/PVDC/AL 70 TABLETS; BLISTER PVC/PE/PVDC/AL 84 TABLETS; BLISTER PVC/PE/PVDC/AL 98 TABLETS; BLISTER
PVC/PE/PVDC/AL 100 TABLETS; BLISTER PVC/PE/PVDC/AL 112 TABLETS
ʪʥʺʮʣʥʮʲ
142-62-32007-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
SANOFI PASTEUR S.A., FRANCE
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
MEDICI LTD
ʯʥʰʩʮʺʸʥʶ
I.M
ʸʩʹʫʺʭʹ
ADACEL POLIO
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
03/02/2010
142-60-31938-00
Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in subjects aged 3 years and over as a booster following primary immunisation . Adacel polio is not
ʤʩʥʥʺʤ
indicatd for primary immunisation. Adacel polio is not indicated for treating diseases caused by B. pertussis, C.Diphtheriae or c. tetani or by poliomyelitis infections.
FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE ; PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE ; FILAMENTOUS HAEMOGGLUTININ (FHA) 5 MCG/DOSE ; PERTACTIN (PRN) ʭʩʡʩʫʸʮ
3 MCG/DOSE ; DIPHTHERIA TOXOID 2LF / 1 DOSES; TETANUS TOXOID 5LF / 1 DOSES; INACTIVATED POLIO VIRUS (IPV) TYPE 1 40DU/DOSE ; INACTIVATED POLIO
VIRUS (IPV) TYPE 2 8DU/DOSE ; INACTIVATED POLIO VIRUS (IPV) TYPE 3 32DU/DOSE
SYRINGE PREFILLED GLASS TYPE I 20 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 1 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 10 x 0.5 ML
ʺʥʦʩʸʠ
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
RAMIPRIL TEVA ® 2.5 MG
03/02/2010
142-59-31880-00
Hypertension congestive heart failure reduction of mortality in patients after MI with left ventricular dysfunction For reducing the risk of myocardial infarction stoke cardiovascular ʤʩʥʥʺʤ
death or need for revascularization procedures in patients over 55 years or more who have clinical evidence of cardiovascular disease (previous MI unstable angina or multivessel
CABG or multivessel PTCA) stroke or peripheral vascular disease. Also for reducing the risk of myocardial infarction stroke cardiovascular death or need for revascularization
procedures in diabetic patients of 55 years or more who have one or more of the following clinical findings : hypertension (systolic blood pressure > 160 mmHg or diastolic pressure
> 90 mmHg) high total cholesterol (>5.2 mmol/L) low HDL ( <0.9 mmol/L) current smoker known microalbuminuria clinical evidence of previous vascular disease. Prevention of
progressive renal failure in patients with persistent proteinuria in excess of 1g/day.
RAMIPRIL 2.5 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS
WYETH PHARMACEUTICALS INC., USA
NEOPHARM LTD
I.V
BENEFIX 2000 IU/VIAL
08/02/2010
142-66-31926-00
Benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or christmas disease), including control and ʤʩʥʥʺʤ
prevention of bleeding in surgical settings, in previously treated patients (PTP) and previously untreated patients (PUP). Benefix is not indicated for the treatment of other factor
deficiencies (e.g. factors II,VII, and X)' nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the
treatment of bleeding due to low levels of liver-dependent coagulation factors.
COAGULATION FACTOR IX RECOMBINANT-RFIX 2000 IU
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 10 ML
VETOQUINOL, FRANCE
LINEVITZ ELIEZER
PER OS
DOLPAC 25 VETERINARY
11/02/2010
For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematodes and cestode species : Nemtodes : toxocara canis toxocaris
leonine ancylostoma caninum uncinaria stenocephala trichuris vulpis. Cestodes : Dipylidum caninum taenia spp.
OXANTEL AS EMBONATE 500.7 MG ; PYRANTEL EMBONATE 124.85 MG ; PRAZIQUANTEL 125 MG
BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS
VETOQUINOL, FRANCE
LINEVITZ ELIEZER
PER OS
DOLPAC 10 VETERINARY
11/02/2010
For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematodes and cestode species : Nemtodes : toxocara canis toxocaris
leonine ancylostoma caninum uncinaria stenocephala trichuris vulpis. Cestodes : Dipylidum caninum taenia spp.
OXANTEL AS EMBONATE 200.28 MG ; PYRANTEL EMBONATE 49.94 MG ; PRAZIQUANTEL 50 MG
BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 6 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS;
BLISTER PVC/ALUMINIUM 30 TABLETS
ʪʥʺʮʣʥʮʲ
142-77-92433-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-76-92430-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
BLUEPHARMA INDUSTRIA FARMACEUT.S.A.,
RAFA LABORATORIES LTD
PER OS
ACROSE 50
PORTUGAL
Treatment of non-insulin dependent diabetes mellitus (NIDDM) in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents.
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
11/02/2010
142-78-31978-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ACARBOSE 50 MG
BLISTER PVC/PE/PVDC/AL 30 TABLETS
BLUEPHARMA INDUSTRIA FARMACEUT.S.A.,
RAFA LABORATORIES LTD
PER OS
ACROSE 100
PORTUGAL
Treatment of non-insulin dependent diabetes mellitus (NIDDM) in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents.
11/02/2010
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ACARBOSE 100 MG
BLISTER PVC/PE/PVDC/AL 30 TABLETS
SYNTHON B.V., NETHERLANDS
INOVAMED LTD
PER OS
142-79-31979-00
ANASTROZOLE INOVAMED 1 MG 11/02/2010
142-73-31916-00
Treatment of advanced breast cancer in post menopausal women. Efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive
ʤʩʥʥʺʤ
clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer
in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
ANASTROZOLE 1 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/PE/PVDC 500 TABLETS; BLISTER PVC/PE/PVDC 10 TABLETS; BLISTER PVC/PE/PVDC 14 TABLETS; BLISTER PVC/PE/PVDC 20 TABLETS; BLISTER
ʺʥʦʩʸʠ
PVC/PE/PVDC 28 TABLETS; BLISTER PVC/PE/PVDC 30 TABLETS; BLISTER PVC/PE/PVDC 50 TABLETS; BLISTER PVC/PE/PVDC 56 TABLETS; BLISTER PVC/PE/PVDC
60 TABLETS; BLISTER PVC/PE/PVDC 84 TABLETS; BLISTER PVC/PE/PVDC 90 TABLETS; BLISTER PVC/PE/PVDC 98 TABLETS; BLISTER PVC/PE/PVDC 100 TABLETS;
BLISTER PVC/PE/PVDC 300 TABLETS
RAFA LABORATORIES LTD, JERUSALEM
RAFA LABORATORIES LTD
PER OS
SBT 8
11/02/2010
142-75-31780-00
Substitution treatment for opioid dependence within a framework of medical, social and psychological treatment.
BUPRENORPHINE AS HYDROCHLORIDE 8 MG
BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 7 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS
RAFA LABORATORIES LTD, JERUSALEM
RAFA LABORATORIES LTD
PER OS
SBT 2
11/02/2010
Substitution treatment for opioid dependence within a framework of medical, social and psychological treatment.
BUPRENORPHINE AS HYDROCHLORIDE 2 MG
BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 7 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS
ʪʥʺʮʣʥʮʲ
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-74-31779-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
RECKITT BENCKISER HEALTHCARE
RECKITT BENCKISER (NEAR EAST) LTD
PER OS
NUROFEN SODIUM IBUPROFEN
11/02/2010
142-71-31929-00
INTERNATIONAL LTD, UK
256 MG
For the symptomatic relief of mild to moderate pain, such as hedache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, the pain of non-serious arthritis, ʤʩʥʥʺʤ
migraine, cold and flu symptoms, sore throat and fever.
IBUPROFEN SODIUM 256 MG
ʭʩʡʩʫʸʮ
BLISTER PVC/ALUMINIUM 24 TABLETS; BLISTER PVC/ALUMINIUM 2 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS;
BLISTER PVC/ALUMINIUM 32 TABLETS; BLISTER PVC/ALUMINIUM 36 TABLETS; BLISTER PVC/ALUMINIUM 48 TABLETS; BLISTER PVC/ALUMINIUM 96 TABLETS;
BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 4 TABLETS; BLISTER PVC/ALUMINIUM 5 TABLETS; BLISTER PVC/ALUMINIUM 6 TABLETS; BLISTER
PVC/ALUMINIUM 8 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 12 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER
PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 16 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS
RECKITT BENCKISER HEALTHCARE
RECKITT BENCKISER (NEAR EAST) LTD
PER OS
NUROFEN SODIUM IBUPROFEN
11/02/2010
INTERNATIONAL LTD, UK
512 MG
For the symptomatic relief of mild to moderate pain, such as hedache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, the pain of non-serious arthritis,
migraine, cold and flu symptoms, sore throat and fever.
IBUPROFEN SODIUM 512 MG
ʺʥʦʩʸʠ
142-72-31944-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
BLISTER PVC/ALUMINIUM 96 TABLETS; BLISTER PVC/ALUMINIUM 2 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 4 TABLETS; BLISTER ʺʥʦʩʸʠ
PVC/ALUMINIUM 5 TABLETS; BLISTER PVC/ALUMINIUM 6 TABLETS; BLISTER PVC/ALUMINIUM 8 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER
PVC/ALUMINIUM 12 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 16 TABLETS; BLISTER
PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 24 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER
PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 32 TABLETS; BLISTER PVC/ALUMINIUM 36 TABLETS; BLISTER PVC/ALUMINIUM 48 TABLETS
BRISTOL MYERS SQUIBB SPA, ITALY
BRISTOL-MYERS SQUIBB (ISRAEL)
PER OS
ABILIFY 30 MG
11/02/2010
142-70-33000-00
LIMITED
Abilify is indicated for the treatment of schizophrenia. And for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode ʤʩʥʥʺʤ
in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
ARIPIPRAZOLE 30 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS
BRISTOL MYERS SQUIBB SPA, ITALY
BRISTOL-MYERS SQUIBB (ISRAEL)
PER OS
ABILIFY 5 MG
11/02/2010
142-68-32994-00
LIMITED
Abilify is indicated for the treatment of schizophrenia. And for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode ʤʩʥʥʺʤ
in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
ARIPIPRAZOLE 5 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS
SANOFI AVENTIS US LLC, USA
SANOFI - AVENTIS ISRAEL LTD
PER OS
Seasonal allergic rhinitis: For the relief of symptoms associated with seasonal allergic rhinitis in children 3 to 11 years of age.
FEXOFENADINE HYDROCHLORIDE 6 MG/ML
BOTTLE PET 30 ML; BOTTLE PET 150 ML; BOTTLE PET 300 ML
ʪʥʺʮʣʥʮʲ
TELFAST SUSPENSION
14/02/2010
142-80-31980-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
GLAXO SMITH KLINE BIOLOGICALS S.A
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
GLAXO SMITH KLINE (ISRAEL) LTD
ʯʥʰʩʮʺʸʥʶ
I.M
ʸʩʹʫʺʭʹ
SYNFLORIX
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
16/02/2010
142-81-32006-00
Active immunisation of infants and children from 6 weeks up to 2 years of age against invasive disease and acute otitis media caused by Streptococcus pneumoniae serotypes 1,4,5, ʤʩʥʥʺʤ
6B, 7F, 9V, 14, 18C, 19F, and 23F.
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 1 MCG / 0.5 ML; PNEUMOCOCCAL
ʭʩʡʩʫʸʮ
POLYSACCHARIDE SEROTYPE 4 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE
SEROTYPE 6B 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 1 MCG /
0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 3 MCG / 0.5 ML;
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 1 MCG / 0.5 ML
VIAL GLASS TYPE I 100 x 1 ML; SYRINGE PREFILLED GLASS 10 x 0.5 ML; VIAL GLASS TYPE I 1 x 0.5 ML; VIAL GLASS TYPE I 10 x 0.5 ML; VIAL GLASS TYPE I 100 x 0.5 ʺʥʦʩʸʠ
ML; SYRINGE PREFILLED GLASS 1 x 0.5 ML; SYRINGE PREFILLED GLASS 10 x 0.5 ML; SYRINGE PREFILLED GLASS 1 x 0.5 ML
PFIZER ITALIA S.R.L., ITALY
PFIZER PHARMACEUTICALS ISRAEL
PER OS
SUTENT 37.5 MG
17/02/2010
142-82-32953-00
LTD
6XWHQWLVLQGLFDWHGIRUWKHWUHDWPHQWRIJDVWURLQWHVWLQDOVWURPDOWXPRUDIWHUGLVHDVHSURJUHVVLRQRQRULQWROHUDQFHWRLPDWLQLEPHV\ODWH
ʤʩʥʥʺʤ
6XWHQWLVLQGLFDWHGIRUWKHWUHDWPHQWRIDGYDQFHGUHQDOFHOOFDUFLQRPD
SUNITINIB AS MALATE 37.5 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVC/ALUMINIUM 7 CAPSULES; BLISTER PVC/ALUMINIUM 28 CAPSULES; BOTTLE HDPE 30 CAPSULES
GENERICS LTD, ENGLAND
GENMEDIX
PER OS
TAMSULOSIN MERCK 0.4 MG
17/02/2010
Treatment of functional symptoms of benign prostatic hyperplasia (BPH).
TAMSULOSIN HYDROCHLORIDE 0.4 MG
BLISTER PVC/PE/PVDC 14 CAPSULES; BLISTER PVC/PE/PVDC 5 CAPSULES; BLISTER PVC/PE/PVDC 7 CAPSULES; BLISTER PVC/PE/PVDC 10 CAPSULES
SAM-ON LTD., BAT-YAM
SAM-ON LTD
RECTAL
GLYCERIN FORTE
SUPPOSITORIES
18/02/2010
For relief of constipation.
STRIPS FOIL 10 SUPPOSITORIES; STRIPS FOIL 20 SUPPOSITORIES; STRIPS FOIL 100 SUPPOSITORIES; STRIPS FOIL 500 SUPPOSITORIES
J-C HEALTH CARE LTD
I.V
YONDELIS
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-84-32039-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
GLYCERIN 3.2G
JANSSEN PHARMACEUTICA N.V.,BELGIUM
142-83-31512-00
18/02/2010
Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
142-85-31830-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
TRABECTEDIN 1 MG/VIAL
VIAL GLASS TYPE I 1 x 1 MG
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
NOVARTIS PHARMA STEIN AG, SWITZERLAND NOVARTIS PHARMA SERVICES AG
PER OS
ʸʩʹʫʺʭʹ
AFINITOR 10 MG
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
22/02/2010
142-87-32046-00
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
EVEROLIMUS 10 MG
BLISTER PA/AL/PVC 30 TABLETS
NOVARTIS PHARMA STEIN AG, SWITZERLAND NOVARTIS PHARMA SERVICES AG
PER OS
AFINITOR 5 MG
22/02/2010
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
EVEROLIMUS 5 MG
BLISTER PA/AL/PVC 30 TABLETS
RECKITT BENCKISER HEALTHCARE INT. LTD, RECKITT BENCKISER (NEAR EAST) LTD
UK
For the symptomatic treatment of mild to moderate pain. For the symptomatic treatment of fever.
RECTAL
NUROFEN SUPPOSITORIES 60
MG
02/03/2010
BLISTER PE/ALUMINIUM 20 SUPPOSITORIES; BLISTER PE/ALUMINIUM 1 SUPPOSITORIES
RECTAL
NUROFEN FOR CHILDREN
SUPPOSITORIES 125 MG
02/03/2010
BLISTER PE/ALUMINIUM 1 SUPPOSITORIES; BLISTER PE/ALUMINIUM 20 SUPPOSITORIES
NASAL
NASIVIN 0.05 %
04/03/2010
Relief of nasal congestion, which is a result of common colds, sinusitis, hay fever or allergies of the upper respiratory system.
BOTTLE PLASTIC 10 ML
NASAL
For temporary relief of nasal congestion due to cold or sinusitis or allergies of the upper respiratory tract.
OXYMETAZOLINE HYDROCHLORIDE 0.5 MG/ML
BOTTLE PLASTIC 10 ML
ʪʥʺʮʣʥʮʲ
142-91-31857-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
OXYMETAZOLINE HYDROCHLORIDE 0.5 MG/ML
MERCK SELBSTMEDIKATION GmbH, GERMANY NAVEH PHARMA LTD
142-89-32016-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
IBUPROFEN 125 MG
MERCK SELBSTMEDIKATION GmbH, GERMANY NAVEH PHARMA LTD
142-88-31900-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
IBUPROFEN 60 MG
RECKITT BENCKISER HEALTHCARE INT. LTD, RECKITT BENCKISER (NEAR EAST) LTD
UK
For the symptomatic treatment of muld to moderate pain. For the symptomatic treatment of fever.
142-86-32045-00
NASIVIN 0.025 %
04/03/2010
142-90-31858-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
AMGEN EUROPE B.V., NETHERLANDS
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
AMGEN EUROPE B.V.
I.V. INFUSION
ʸʩʹʫʺʭʹ
VECTIBIX 20 MG/ML
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
04/03/2010
142-92-32951-00
Monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine, oxaliplatin, and ʤʩʥʥʺʤ
irinorecan - containing chemotherapy regimens.
PANITUMUMAB 20 MG / 1 ML
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 20 ML; VIAL GLASS TYPE I 1 x 5 ML; VIAL GLASS TYPE I 1 x 10 ML
RANBAXY UK LTD
CTS LTD
PER OS
SERTRALINE 50 MG TABLETS
07/03/2010
For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertaline therapy is effective in
preventing relapse of the initial episode of depression or recurrence of further depressive episodes.
SERTRALINE AS HYDROCHLORIDE 50 MG
BLISTER PVC/PVDC/ALUMINIUM 100 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 20 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS; BLISTER
PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 50 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 98 TABLETS
RANBAXY UK LTD
CTS LTD
PER OS
SERTRALINE 100 MG TABLETS
07/03/2010
For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertaline therapy is effective in
preventing relapse of the initial episode of depression or recurrence of further depressive episodes.
SERTRALINE AS HYDROCHLORIDE 100 MG
BLISTER PVC/PVDC/ALUMINIUM 100 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 20 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS; BLISTER
PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 50 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 98 TABLETS
BOEHRINGER INGELHEIM PHARMA GmbH &
RAFA LABORATORIES LTD
PER OS
PRADAXA 110
08/03/2010
CO.KG
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
142-93-31678-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-94-31679-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-96-32974-00
ʤʩʥʥʺʤ
DABIGATRAN ETEXILATE 110 MG
ʭʩʡʩʫʸʮ
BOTTLE POLYPROPYLENE 10 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 10 CAPSULES; BOTTLE POLYPROPYLENE 30 CAPSULES; BOTTLE POLYPROPYLENE 60 ʺʥʦʩʸʠ
CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 60 CAPSULES
BOEHRINGER INGELHEIM PHARMA GmbH &
RAFA LABORATORIES LTD
PER OS
PRADAXA 75
08/03/2010
CO.KG
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
DABIGATRAN ETEXILATE 75 MG
BLISTER ALUMINIUM /ALUMINIUM 10 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BOTTLE POLYPROPYLENE 10 CAPSULES; BOTTLE
POLYPROPYLENE 30 CAPSULES; BOTTLE POLYPROPYLENE 60 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 60 CAPSULES
TEVA PHARMACEUTICAL INDUSTRIES LTD
TEVA PHARMACEUTICAL INDUST.LTD
PER OS
TAMOXIFEN TEVA ® 10 MG
09/03/2010
For the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities.
TAMOXIFEN AS CITRATE 10 MG
BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 100 TABLETS; BLISTER PVDC/ALUMINIUM 250
TABLETS
ʪʥʺʮʣʥʮʲ
142-95-32973-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
142-97-33083-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TEVA PHARMACEUTICAL INDUSTRIES LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
TEVA PHARMACEUTICAL INDUST.LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
09/03/2010
142-98-33084-00
TAMOXIFEN TEVA ® 20 MG
For the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities.
TAMOXIFEN AS CITRATE 20 MG
BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 100 TABLETS; BLISTER PVDC/ALUMINIUM 250
TABLETS
JERINI AG, GERMANY
MEDISON PHARMA LTD
S.C
FIRAZYR 30 MG
11/03/2010
Symptomatic treatment of acute attacks of hereditary angioedima (HAE) in adults (with C1 -esterase-inhibitor deficiency).
SYRINGE PREFILLED GLASS TYPE I 1 x 3 ML
DEVRIES & CO. LTD
PER OS
ASPIRIN CARDIO
15/03/2010
The primary prevention of coronary heart disease in patients at increased risk and the secondary prevention of thrombotic cerebrovascular or cardiovascular disease.
BLISTER POLYPROPYLENE/ALUMINIUM 3 x 10 TABLETS
BIOAVENIR LTD
I.V
ACYCLOVIR BIOAVENIR
143-06-31982-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ACETYLSALICYLIC ACID 100 MG
LABORATORY REIG JOFRE S.A., SPAIN
142-99-33003-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
ICATIBANT AS ACETATE 30 MG / 3 ML
BAYER BITTERFELD GmbH, GERMANY
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
16/03/2010
143-05-31907-00
For the treatment of Herpes Simplex infections and severe intial genital herpes in the non immunocompromised. For the prophylaxis of Herpes Simplex infections in immuneʤʩʥʥʺʤ
compromised patients. In the treatment of Varicella zoster infections. For Herpes Simplex Encephalitis. For the treatment of herpes simplex infection in the neonate and infant up to 3
months of age.
ACYCLOVIR 250 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE II 5 x 10 ML; VIAL GLASS TYPE II 50 x 10 ML
WEST PHARMA- PROD. DE ESPEC.
BIOAVENIR LTD
PER OS
ALENDRONATE BIOAVENIR
16/03/2010
FARMACEUT.S.A.
Alendronate Bioavenir is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression
fractures) .
ALENDRONIC ACID AS SODIUM 70 MG TRIHYDRATE
BLISTER ALUMINIUM 12 TABLETS; BLISTER ALUMINIUM 2 TABLETS; BLISTER ALUMINIUM 4 TABLETS; BLISTER ALUMINIUM 8 TABLETS
CP-PHARMA GmbH, GERMANY
A.VETERINARY SUPPLY LTD
143-03-31906-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
PER OS
PREDNISOLON 5 MG
16/03/2010
143-01-92414-00
VETERINARY
For use in dogs and cats: - rheumatological/orthopaedic disorders: rheumatoid arthritis arthritis deformans bursitis tendinitis periarthritis. - respiratory disorders allergic
ʤʩʥʥʺʤ
bronchitis. - gastroenterological disorders chronic active hepatitis. - ophthalmological disorders disorders of the posterior optical segment such as chorioretinitis papillitis optic
neuritis. -dermatological disorders anti-inflammatory: pyotraumatic dermatitis allergic dermatitis contact dermatitis urticaria idiopathic seborrhoeic dermatitis acral lick dermatitis
juvenile cellulitis. - immunosuppressive lupus erythematosus.
PREDNISOLONE 5 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVC/PVDC 10 TABLETS; BOTTLE HDPE 100 TABLETS
ʪʥʺʮʣʥʮʲ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
CP-PHARMA GmbH, GERMANY
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
ʯʥʰʩʮʺʸʥʶ
A.VETERINARY SUPPLY LTD
ʸʩʹʫʺʭʹ
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
PER OS
PREDNISOLON 50 MG
16/03/2010
143-04-92415-00
VETERINARY
For use in dogs and cats: - rheumatological/orthopaedic disorders: rheumatoid arthritis arthritis deformans bursitis tendinitis periarthritis. - respiratory disorders allergic
ʤʩʥʥʺʤ
bronchitis. - gastroenterological disorders chronic active hepatitis. - ophthalmological disorders disorders of the posterior optical segment such as chorioretinitis papillitis optic
neuritis. -dermatological disorders anti-inflammatory: pyotraumatic dermatitis allergic dermatitis contact dermatitis urticaria idiopathic seborrhoeic dermatitis acral lick dermatitis
juvenile cellulitis. - immunosuppressive lupus erythematosus.
PREDNISOLONE 50 MG
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
BLISTER PVC/PVDC 10 TABLETS
NOVO NORDISK A/S, DENMARK
NOVO NORDISK LTD
S.C
VICTOZA
18/03/2010
)RUWKHWUHDWPHQWRIDGXOWVZLWKW\SHGLDEHWHVPHOOLWXVWRDFKLHYHJO\FHPLFFRQWURO
LQFRPELQDWLRQZLWK
0HWIRUPLQRUDVXOSKRQ\OXUHDLQSDWLHQWVZLWKLQVXIILFLHQWJO\FHPLFFRQWUROGHVSLWHPD[LPDOWROHUDWHGGRVHRIPRQRWKHUDS\ZLWKPHQWIRUPLQRUVXOSKRQ\OXUHD
0HWIRUPLQDQGVXOSKRQ\OXUHDRUPHWIRUPLQDQGWKLD]ROLGLQHGLRQHLQSDWLHQWVZLWKLQVXIILFLHQWJO\FHPLFFRQWUROGHVSLWHGXDOWKHUDS\
LIRAGLUTIDE 6.0MG/ML
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
PRE FILLED PEN GLASS TYPE I 2 x 3 ML
V.M.D. N.V., BELGIUM
UDIM PHARMACY
I.M; I.V
TILOVETO - 20 VETERINARY
143-07-32987-00
25/03/2010
Infectious diseases in cattle caused by Gram-positive bacteria and mycoplasms sensitive to Tylosine.
143-08-92400-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
TYLOSIN AS TARTRATE 200 MG/ML
BOTTLE AMBER GLASS TYPE II 100 ML
ORION CORPORATION, FINLAND
PFIZER PHARMACEUTICALS ISRAEL
I.M; I.V
DEXDOMITOR VETERINARY
12/04/2010
143-09-92440-00
LTD
Non-invasive mildly to moderately painful procedures and examinations which require restraint sedation and analgesia in dogs and cats. Premedication in cats before induction
ʤʩʥʥʺʤ
and maintenance of general anaesthesia with ketamine. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.
Premedication in dogs before induction and maintenance of general anaesthesia.
DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
VIAL GLASS TYPE I 1 x 10 ML
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD
UNIPHARM LTD
PER OS
STATOR 5
13/04/2010
143-12-33069-00
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia ) or mixed dyslipidaemia ( type IIb ) as an adjunct to diet when response to diet and ʤʩʥʥʺʤ
other non-pharmacological treatments (e.g. exercise weight reduction) is inadequate. Hormozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering
treatments (e.g. LDL apheresis) or if such treatment are not appropriate.
ROSUVASTATIN AS CALCIUM 5 MG
ʭʩʡʩʫʸʮ
BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS
ʪʥʺʮʣʥʮʲ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
UNIPHARM LTD
ʯʥʰʩʮʺʸʥʶ
PER OS
ʸʩʹʫʺʭʹ
STATOR 10
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
13/04/2010
143-13-31932-00
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and
other non-pharmacological treatments (e.g. exercise weight reduction ) is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering
treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
ROSUVASTATIN AS CALCIUM 10 MG
BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD
PER OS
STATOR 20
13/04/2010
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and
other non-pharmacological treatments (e.g. exercise weight reduction ) is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering
treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
ROSUVASTATIN AS CALCIUM 20 MG
BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS
TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD
PER OS
STATOR 40
13/04/2010
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and
other non-pharmacological treatments (e.g. exercise weight reduction ) is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering
treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
ROSUVASTATIN AS CALCIUM 40 MG
BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER
ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS
EBEWE PHARM GES.m.b.H NFG. KG, AUSTRIA PHARMALOGIC LTD
I.V
GEMCITABIN " EBEWE " 200 MG 13/04/2010
3DOOLDWLYHWUHDWPHQWRISDWLHQWVZLWKORFDOO\DGYDQFHGRUPHWDVWDWLFQRQVPDOOFHOOOXQJFDQFHUDQGORFDOO\DGYDQFHGRUPHWDVWDWLFDGHQRFDUFLQRPDRIWKHSDQFUHDVDQGIRUSDWLHQWV
ZLWK)8UHIUDFWRU\SDQFUHDWLFFDQFHU*HPFLWDELQHLVLQGLFDWHGIRUWKHWUHDWPHQWRISDWLHQWVZLWKEODGGHUFDQFHUDWWKHLQYDVLYHVWDJH
%UHDVWFDQFHU
*HPFLWDELQHLQFRPELQDWLRQZLWKSDFOLWD[HOLVLQGLFDWHGIRUWKHWUHDWPHQWRISDWLHQWVZLWKXQUHVHFWDEOHORFDOO\UHFXUUHQWRUPHWDVWDWLFEUHDVWFDQFHUZKRKDYHUHODSVHGIROORZLQJ
DGMXYDQWQHRDGMXYDQWFKHPRWKHUDS\3ULRUFKHPRWKHUDS\VKRXOGKDYHLQFOXGHGDQDQWKUDF\FOLQHXQOHVVFOLQLFDOO\FRQWUDLQGLFDWHG
2YDULDQFDQFHU
*HPFLWDELQHLQFRPELQDWLRQZLWKFDUERSODWLQLVLQGLFDWHGIRUWKHWUHDWPHQWRISDWLHQWVZLWKUHFXUUHQWHSLWKHOLDORYDULDQFDUFLQRPDZKRPKDYHUHODSVHGDWOHDVWVL[PRQWKVDIWHU
SODWLQXPEDVHGWKHUDS\
GEMCITABINE AS HYDROCHLORIDE 200 MG
VIAL GLASS TYPE I 1 x 10 ML
ʪʥʺʮʣʥʮʲ
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
143-14-31933-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
143-15-31934-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
143-10-33099-00
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
ʺʥʦʩʸʠ
Ministry of Health
Pharmaceutical Administration
Drug Registration Department
ʯʸʶʩ
EBEWE PHARM GES.m.b.H NFG. KG, AUSTRIA
ʺʥʠʩʸʡʤʣʸʹʮ
ʺʥʧʷʥʸʤʳʢʠ
ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ
ʬʠʸʹʩʺʰʩʣʮ
STATE OF ISRAEL
ʭʥʹʩʸʬʲʡ
PHARMALOGIC LTD
ʯʥʰʩʮʺʸʥʶ
I.V
ʸʩʹʫʺʭʹ
GEMCITABIN "EBEWE" 1 G
ʭʥʹʩʸʪʩʸʠʺ
ʸʩʹʫʺʸʴʱʮ
13/04/2010
143-11-33116-00
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GEMCITABINE AS HYDROCHLORIDE 1000 MG
VIAL GLASS TYPE I 1 x 50 ML
ʪʥʺʮʣʥʮʲ
ʤʩʥʥʺʤ
ʭʩʡʩʫʸʮ
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