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Dossiers d'AMM à évaluer par la commission spécialisée des Biosimilaires du 29/03/2022

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

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