Key Benefits:
New requests for the month of October 2003
Executing provisions in R. 5140
of the Public Health Code (Part 2)
Speciality named ALTEIS 10 mg, pelliculated tablet:
Laboratories Menarini International Operations Luxembourg.
Composition: olmesartan medoxomil 10 Mg. -AMM n ° s 362 944.8 (14 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]); 362 945.4 (28 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]); 362 946.0 (56 tablets in platelets) Thermoformed [polyamide/aluminium/PVC/aluminium]); 362 947.7 (98 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]) (decision of 29 October 2003).
Speciality called ALTEIS 20 mg, pelliculated tablet:
Laboratoires Menarini International Operations Luxembourg.
Composition: olmesartan medoxomil 20 mg. -AMM n ° s 362 948.3 (14 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]); 362 950.8 (28 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]); 362 951.4 (56 tablets in platelets) Thermoformed [polyamide/aluminium/PVC/aluminium]); 362 952.0 (98 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]) (decision of 29 October 2003).
Speciality called ALTEIS 40 mg, pelliculated tablet:
Laboratoires Menarini International Operations Luxembourg.
Composition: olmesartan medoxomil 40 mg. -AMM n ° s 362 953.7 (14 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]); 362 954.3 (28 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]); 362 956.6 (56 tablets in platelets) Thermoformed [polyamide/aluminium/PVC/aluminium]); 362 957.2 (98 tablets on thermoformed platelets [polyamide/aluminium/PVC/aluminium]) (decision of October 29, 2003).
Specialty: AMAREL 6 mg, compressed:
Laboratory Aventis.
Composition: glimepiride 6 mg, for a tablet. -AMM n ° s 363 100.8 (30 tablets on thermoformed platelets [PVC/aluminium]); 564 975.1 (120 tablets on thermoformed platelets [PVC/aluminium]) (decision of 29 October 2003).
Specialty: AMISULPRIDE ARROW 200 mg, compressed tablet :
Gayrard Pascale.
Composition: amisulpride 200 mg, for an age-old tablet. -AMM n ° s 362 863.8 (30 tablets under heat-formed platelets [PVC/aluminium]); 362 864.4 (60 tablets on thermoformed platelets [PVC/aluminium]); 565 059.9 (150 hot-formed tablets [PVC/aluminium]); this specialty is a Generic of SOLIAN 200 mg, compressed (decision of October 29, 2003).
Specialty named AMISULPRIDE SUBSTIPHARM 200 mg, compressed tablet:
Laboratories Substipharm.
Composition: amisulpride 200 mg, for an age-old tablet. -AMM n ° s 363 260.5 (30 tablets under heat-formed platelets [PVC/aluminium]); 363 261.1 (60 tablets on thermoformed platelets [PVC/aluminium]); 565 212.1 (150 tablets on thermoformed platelets [PVC/aluminium]); this specialty is a Generic of SOLIAN 200 mg, compressed (decision of October 29, 2003).
Speciality named BICIRKAN, pelliculated tablet:
Pierre Fabre medicament.
Composition: dry extract of small hops 80 mg; hespéridine methylchalcone 200 mg; acid Ascorbic 400 mg, for a pelliculate tablet. -AMM n ° s 363 096.0 (30 tablets on thermoformed platelets [PVC/ACLAR/aluminium]); 363 097.7 (30 tablets on thermoformed platelets [polyamide-aluminium/aluminium]); 363 098.3 (30 tablets in flask [PE]) (decision of 29 October 2003).
Specialty: BISOPROLOL MERCK LIPHA HEALTH 10 mg, secular film tablet:
Merck Lipha Health.
Composition: bisoprolol hemifumarate 10 mg, for a secable pelliculate tablet. -AMM n ° s 361 246.5 (28 tablets under heat-formed platelets [PVC/PVDC/aluminium]); 361 247.1 (30 hot-formed tablets [PVC/PVDC/aluminium]); 564 661.7 (50 tablets under heat-formed platelets [PVC/PVDC/aluminium]); this Specialty is a generic of DETENSIEL 10 mg, secular film tablet (decision of October 29, 2003).
Specialty: DOMPERIDONE RPG 10 mg, pelliculated tablet:
Janssen Cilag SA.
Composition: domperidone 10 mg. -AMM n ° s 362 687.5 (30 tablets on thermoformed platelets [aluminium/PVC]); 362 688.1 (40 tablets on thermoformed platelets [aluminium/PVC]); this specialty is a generic version of motilium 10 mg, pelliculated tablet (decision of 29 October 2003).
Specialty named DRYTEC, molybdenum generator [99MB] /technetium [99mTc]:
Amersham Health SA.
Composition: parent radionuclide: 99MB; filiation radionuclide: 99mTc. -AMM n ° 564 454.1 (5-7.5-10-15-20-25 [99MB] GBq at the reference date) (decision of October 29, 2003).
ELSEP 2 mg/ml, diluent solution for infusion:
Wyeth-Lederlé.
Composition: mitoxantrone 2 mg; Form of mitoxantrone hydrochloride for 1 mL. -AMM n ° s 564 344.1 (5 ml in bottle [glass]); 564 345.8 (10 ml in bottle [glass]); 564 346.4 (12.5 ml in bottle [glass]) (decision of October 29, 2003).
Specialty named FLUOXETINE IVAX 20 mg, capsule:
Ivax Laboratory.
Composition: Fluoxetine base, 20.00 mg; in the form of fluoxetine hydrochloride, for a capsule. -AMM n ° s 363 125.0 (14 plates in thermoformed platelets [PP/aluminium]); 565 136.3 (70 plates in thermoformed platelets [PP/aluminium]); this specialty is a generic PROZAC 20 mg, capsule (decision of October 29, 2003).
Specialty GYMISO 200 micrograms, compressed:
Laboratoire HRA Pharma.
Composition: misoprostol 200 micrograms; in the form of 1 % dispersion of misoprostol in the hypromellose 20.00 mg, for a tablet. -AMM No 362 499.4 (2 thermostoned film tablets [paper/PE/aluminium]) (decision of 29 October 2003).
Specialty: QUINAPRIL MERCK 40 mg, pelliculated tablet:
Generic Merck Lab.
Composition: quinapril 40.00 mg; As a quinapril hydrochloride, for 1 pelliculate tablet. -AMM n ° s 362 468.1 (28 tablets on thermoformed platelets [PVC/aluminium]); 564 963.3 (50 tablets on thermoformed platelets [PVC/aluminium]) (decision of 29 October 2003).
Speciality called MAGNEVIST 2 mmol/l, injectable solution in Pre-filled syringe (intra-articular route):
Laboratoire Schering SA.
Composition: gadopentetate of dimmer 2 mmol (or 1.876 g); equivalent to gadolinium 0.32 g, for 1 l of solution. -AMM n ° s 362 487.6 (20 ml in pre-filled syringe [glass]; box of 1); 564 973.9 (20 ml in prefilled syringe [glass]; box of 5) (decision of 29 October 2003).
Specialty: MISSILOR 750 000 IU/125 mg, tablet film:
Laboratory Pierre Fabre medication.
Composition: spiramycin 750 000 IU; metronidazole 125.00 mg, for a pelliculate tablet. -AMM No 361 936.1 (20 tablets on thermoformed platelets [PVC/aluminium]); this specialty is a generic of RODOGYL, pelliculated tablet (decision of October 7, 2003).
Speciality called MISSONNETTE 2 x 75 mg, implant:
Laboratory Schering SA.
Composition: levonorgestrel 75 mg, for implant. -AMM No 362 485.3 (2 Implants in sachet-dose [PE/PET/PE]) (decision of 20 October 2003).
MOCLOBEMIDE G GAM 150 mg, secular tablet:
Laboratories G Gam.
Composition: moclobemide 150 mg, for a tablet Secular dandruff. -AMM n ° s 362 684.6 (30 tablets under heat-formed platelets [PVC/aluminium]); 362 685.2 (50 tablets on thermoformed platelets [PVC/aluminium]); 362 686.9 (100 tablets on thermoformed platelets [PVC/aluminium]); this specialty is a Generic MOCLAMINE 150 mg, secular film tablet (decision of October 29, 2003).
Specialty named MYFORTIC 180 mg, gastroresistant tablet:
Laboratoire Novartis Pharma SAS.
Composition: mycophenolic acid 180.00 Mg; in the form of sodic mycophenol 192.40 mg, for a gastroresistant tablet. -AMM n ° s 363 084.2 (20 tablets on thermoformed platelets [polyamide/aluminium/PVC]); 363 085.9 (50 tablets on thermoformed platelets [polyamide/aluminium/PVC]); 363 086.5 (100 tablets on thermoformed platelets) [polyamide/aluminium/PVC]); 363 087.1 (120 tablets on thermoformed platelets [polyamide/aluminium/PVC]); 363 088.8 (250 tablets on thermoformed platelets [polyamide/aluminium/PVC]) (decision of 10 October 2003).
Specialty: MYFORTIC 360 mg, gastro-resistant tablet:
Laboratoire Novartis Pharma SAS.
Composition: mycophenolic acid 360.00 mg; in the form of a sodium mycophenolic 384.80 mg, for a gastroresistant coated tablet. -AMM n ° s 363 089.4 (50 tablets on thermoformed platelets [polyamide/aluminium/PVC]); 363 090.2 (100 tablets on thermoformed platelets [polyamide/aluminium/PVC]); 363 091.9 (120 tablets on thermoformed platelets) [polyamide/aluminium/PVC]); 363 092.5 (250 tablets on thermoformed platelets [polyamide/aluminium/PVC]) (decision of October 10, 2003).
Specialty named NOVOPULMON NOVOLIZER 200 micrograms/dose, inhalation powder:
Viatris Pharmaceuticals.
Composition: budesonide 200 micrograms for one dose. -AMM n ° 362 937.1 (100 doses in cartridge [polystyrene/polypropylene]; box 1 with inhaler); 362 938.8 (200 doses in cartridge [polystyrene/polypropylene]; box of 1 with inhaler); 362 939.4 (200 doses in canister) [polystyrene/polypropylene]; box 2 with inhaler); 362 940.2 (200 doses in cartridge [polystyrene/polypropylene]; box of 1); 362 941.9 (200 doses in cartridges [polystyrene/polypropylene]; box 2); 564 974.5 (100 doses in canister [polystyrene/polypropylene]; box of 10 with inhaler) (decision of 29 October 2003).
Speciality called PARACETAMOL PRONIER 3 % CHILDREN AND NOURRISSONS, drinkable solution:
Laboratoires Fournier SA.
Composition: paracetamol 3.00 g, For 100 ml of drinkable solution. -AMM No. 362 182.0 (90 ml bottle [PET] + doser device [polystyrene]) (decision of October 29, 2003).
Specialty named PERIDYS 20 mg, age-old pelliculate:
Pierre Fabre drug.
Composition: domperidone 20 mg, for a Secular film tablet. -AMM n ° s 362 488.2 (20 tablets under heat-formed platelets [PVC/aluminium]); 362 489.9 (40 tablets under heat-formed platelets [PVC/aluminium]); 362 490.7 (100 tablets on thermoformed platelets [PVC/aluminium]) (decision of 20 October 2003).
Speciality named RISPERDALCONSTA LP 25 mg/2 ml, powder and solvent for long-release injectable suspension in prefilled syringe:
Janssen Cilag.
Composition: risperidone 25 mg, for a vial. -AMM No. 362 491.3 (flask powder + 2 ml of solvent in prefilled syringe [glass]; box of 1) (decision of 7 October 2003).
Speciality named RISPERDALCONSTA LP 37.5 mg/2 ml, powder and solvent for suspension injectable suspension Prefilled syringe:
Janssen Cilag.
Composition: risperidone 37.5 mg, for a vial. -AMM n ° 362 493.6 (powder in bottle [glass] + 2 ml of solvent in prefilled syringe [glass]; box of 1) (decision of October 7, 2003).
Speciality named RISPERDALCONSTA LP 50 mg/2 ml, powder and solvent for suspension injectable suspension Long-term syringe:
Janssen Cilag.
Composition: risperidone 50 mg, for a vial. -AMM No. 362 494.2 (powder in bottle [glass] + 2 ml of solvent in prefilled syringe [glass]; box of 1) (decision of October 7, 2003).
named SIMVASTATINE QUALIMED 40 mg, pelliculated tablet:
Laboratoire Qualimed.
Composition: simvastatin 40 mg, for a pelliculate tablet. -AMM No. s 362 856.1 (28 tablets under heat-formed platelets [PVC/PVDC/aluminium]); 362 857.8 (30 hot-formed tablets [PVC/PVDC/aluminium]); 565 050.1 (50 hot-formed platelets [PVC/PVDC/aluminium]); 362 858.4 (28 hot-formed platelet tablets [PVC/PVDC/aluminium]); 362 859.0 (30 hot-formed platelet tablets [PVC/PVDC/aluminium]); 565 051.8 (50 hot-formed platelet tablets [PVC/PVDC/aluminium]); 362 860.9 (28 tablets in Pilulier [HDPP]); 362 861.5 (30 pills [HDPP]); 565 052.4 (50 tablets in piluar [HDPP]); this specialty is a generic of ZOCOR 40 mg, pelliculated tablet (decision of October 29, 2003).
Specialty TUSSIDANE 3 mg/ml WITHOUT SUGAR, drinkable solution sweetened to liquid maltitol and sodium saccharin:
Laboratoire des Accomplishments Therapeutic Elerté.
Composition: dextromethorphan hydrobromide 3 mg, for 1 ml of oral solution. -AMM n ° s 362 854.9 (125 ml in bottle [glass] with teaspoon [polystyrene]); 362 855.5 (150 ml bottle [glass] with teaspoon [polystyrene]); 362 710.7 (200 ml bottle [glass] with teaspoon [polystyrene]) (decision of October 29) 2003).
