Key facts

Active Substance
Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec)
Therapeutic area
Other
Decision number
P/0309/2020
PIP number
EMEA-002571-PIP01-19
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of X linked myotubular myopathy
Route(s) of administration
Intravenous use
Contact for public enquiries

Astellas Pharma Europe B.V.
Tel. +31 7154 55878
E-mail: contact.nl@astellas.com 

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

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