EMEA-002070-PIP01-16-M06

Table of contents

Key facts

Invented name
Evrysdi
Active substance
Risdiplam (RO7034067)
Therapeutic area
Neurology
Decision number
P/0470/2021
PIP number
EMEA-002070-PIP01-16-M06
Pharmaceutical form(s)
Powder for oral solution
Condition(s) / indication(s)
Treatment of spinal muscular atrophy
Route(s) of administration
Oral use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 616879411
E-mail: info.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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