EMEA-002168-PIP01-17-M04

Table of contents

Key facts

Invented name
Zolgensma
Active substance
Onasemnogene abeparvovec
Therapeutic area
Neurology
Decision number
P/0015/2022
PIP number
EMEA-002168-PIP01-17-M04
Pharmaceutical form(s)
Solution for injection/infusion
Condition(s) / indication(s)
Treatment of spinal muscular atrophy
Route(s) of administration
  • Intravenous use
  • Intrathecal use
Contact for public enquiries
Novartis Gene Therapy EU Limited
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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