Reason for request
Renouvellement d'inscription et Extension d'indication
Elargissement de l’utilisation aux enfants de 2 à 18 ans
Clinical Benefit
| Substantial |
Le service médical rendu par SMOFKABIVEN reste important dans l’indication de l’AMM. |
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
B7rj1na4EF1YatVh
Listen
