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Transparency Committee Opinion

ZOMACTON

Active substance (DCI)
  • somatropin

Reason for request
Re-assessment of AB in accordance with Article R 163-21 of the social security code.

Date 07 December 2011

Actual benefit

Important Prenant en compte l'ensemble des données étudiées le service médical rendu par ZOMACTON dans le syndrome de Turner est important.


Improvement in actual benefit

IV (mineur) ZOMACTON apporte une amélioration du service médical rendu mineure (ASMR IV) dans la prise en charge du syndrome de Turner.


Documents

English version

ATC Code
  • H01AC01
Laboratory / Manufacturer
FERRING SAS

Presentation

ZOMACTON 10 mg/ml, powder and solvent for solution for injection in pre-filled syringe
B/1 vial + one 1 ml pre-filled syringe (CIP code: 370 840-3)
ZOMACTON 4 mg, powder and solvent for solution for injection in multidose container
B/1 vial + one 3.5 ml ampoule (CIP code: 342 154-1)

Posted on Mar 19 2013