Dossiers d'AMM à évaluer par la commission spécialisée des Biosimilaires du 29/03/2022
N° | PRODUIT | DCI | LABORATOIRE | MOTIF |
1 | NEPEXTO 50 mg/ ml Solution injectable B/4 seringues | ETANERCEPT | MYLAN IRE HEALTHCARE- Irlande | AMM |
2 | NEPEXTO 25mg/ml Solution injectable B/8 seringues | ETANERCEPT | MYLAN IRE HEALTHCARE- Irlande | AMM |
3 | NEPEXTO 50 mg / ml Solution injectable B/4 stylos | ETANERCEPT | MYLAN IRE HEALTHCARE- Irlande | AMM |
4 | HYRIMOZ 40 mg Solution injectable B/2 stylos | ADALIMUMAB | SANDOZ Gmbh- Autriche | AMM |
5 | HYRIMOZ 40 mg Solution injectable B/2 seringues | ADALIMUMAB | SANDOZ Gmbh- Autriche | AMM |
6 | IDACIO 40 mg Solution injectable B/2 seringues | ADALIMUMAB | FRESINUS KABI-France | AMM |
7 | REMSIMA 120 mg Solution injectable B/1 stylo | INFLIXIMAB | HIKMA - Jordanie | AMM |
8 | REMSIMA 120 mg Solution injectable B/2 stylos | INFLIXIMAB | HIKMA - Jordanie | AMM |
9 | REMSIMA 120 mg Solution injectable B/4 stylos | INFLIXIMAB | HIKMA - Jordanie | AMM |
10 | REMSIMA 120 mg Solution injectable B/4 seringues | INFLIXIMAB | HIKMA - Jordanie | AMM |
11 | OGIVRI 150 mg Pdre pour sol inj Fl/15 ml | TRASTUZUMAB | MYLAN SAS- France | AMM |
12 | OGIVRI 420 mg Pdre pour sol inj Fl/15 ml | TRASTUZUMAB | MYLAN SAS- France | AMM |
13 | INSUGEN R 100 UI/ml B/1FL/ 10 ml | INSULINE HUMAINE | MEDIS- Tunisie | AMM |
14 | INSUGEN R REFIL 100 UI/ml B/5 cartouches | INSULINE HUMAINE | MEDIS- Tunisie | AMM |
15 | BLASTOFERON 22 µg (6 M I.U) sol inj B/12 ser pré-remplies | INTERFERON BETA-1A | BIO SIDUS S.A Argentine | AMM |
16 | BLASTOFERON 44 µg (12 M U.I) sol inj B/12 ser pré-remplies | INTERFERON BETA-1A | BIO SIDUS S.A Argentine | AMM |
17 | RECIGEN 44µg sol inj B/12 ser pré-remplies | INTERFERON BETA-1A | CINNAGEN Co Iran | AMM |
18 | NEUTROMAX 30 UI solution injectbale B/1Fl | FILGRASTIM | BIOSIDUS ARGENTINE | INDICATIONS |
19 | NEUTROMAX 48 UI solution injectbale B/1Fl | FILGRASTIM | BIOSIDUS ARGENTINE | INDICATIONS |
20 | HEMAX 2000 UI Pdre pour préparation injectable B/25 FL | EPOEITINE ALFA | BIOSIDUS ARGENTINE | INDICATIONS |