EMEA-000115-PIP01-07-M10

Key facts

Invented name
Translarna
Active substance
Ataluren
Therapeutic area
Neurology
Decision number
P/0335/2019
PIP number
EMEA-000115-PIP01-07-M10
Pharmaceutical form(s)
Granules for oral suspension
Condition(s) / indication(s)
Treatment of dystrophinopathy
Route(s) of administration
Oral use
Contact for public enquiries
PTC Therapeutics International Limited

Tel. +353 19068700
E-mail: medinfo@ptcbio.com

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

Decision

How useful was this page?

Add your rating