EMEA-000115-PIP01-07-M09

Key facts

Invented name
Translarna
Active substance
Ataluren
Therapeutic area
Neurology
Decision number
P/0393/2017
PIP number
EMEA-000115-PIP01-07-M09
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

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