EMEA-000115-PIP01-07-M08

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Overview

Product details for Translarna
Invented nameTranslarna
Active substance

Ataluren

Decision numberP/0283/2016
PIP numberEMEA-000115-PIP01-07-M08
Pharmaceutical form(s)Granules for oral suspension
Condition(s)/indication(s)

Treatment of dystrophinopathy

Route(s) of administrationOral use
PIP applicant

PTC Therapeutics International Limited
Ireland
Tel. +353 19068700
E-mail: medinfo@ptcbio.com

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

Decision