Key facts

Invented name
Translarna
Active Substance
Ataluren
Therapeutic area
Neurology
Decision number
P/0195/2021
PIP number
EMEA-000115-PIP01-07-M12
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
RPM: decision refers to a refusal on the application for modification of an agreed PIP
Decision date

Decision

P/0477/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M12)

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