Avis relatif à l'octroi d'autorisations d'importation parallèle de spécialités pharmaceutiques
| Jurisdiction | France |
| Publication au Gazette officiel | JORF n°0116 du 21 mai 2015 |
| Record Number | JORFTEXT000030617294 |
| Court | Ministère des affaires sociales, de la santé et des droits des femmes |
| Date de publication | 21 mai 2015 |
Exécution des dispositions de l'article R. 5121-123 du code de la santé publique
Mars 2015
Spécialité dénommée CADUET 5 mg/10 mg, comprimé pelliculé
Code identifiant de spécialité : 6 670 996 3
Pays de provenance : RÉPUBLIQUE TCHÈQUE
PHARMA LAB
amlodipine5 mg
sous forme de bésilate d'amlodipine
atorvastatine10 mg
sous forme d'atorvastatine calcique trihydratée
Pour un comprimé
Code(s) identifiant(s) de présentation :
34009 490 002 1 0 : 30 comprimés sous plaquettes thermoformées (polyamide/aluminium/PVC)
Cette spécialité pharmaceutique importée de République tchèque, est autorisée à être mise sur le marché parallèlement à la spécialité pharmaceutique CADUET 5 mg/10 mg, comprimé pelliculé ayant obtenu une autorisation de mise sur le marché en France.
Décision du 6 mars 2015.
Spécialité dénommée GRANOCYTE 34 millions UI/ML, poudre et solvant pour solution injectable/perfusion en seringue préremplie
Code identifiant de spécialité : 6 399 215 7
Pays de provenance : LITUANIE
MEDIWIN Limited
lénograstim 33,6 millions UI (263 microgrammes)
Pour un flacon
Code(s) identifiant(s) de présentation :
34009 490 002 8 9 : poudre en flacon (en verre) ; boîte de 1 + 1 ml en seringue préremplie (en verre) ; boîte de 1
Cette spécialité pharmaceutique importée de Lituanie est...
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