EMEA-000115-PIP01-07-M08

  • Email
  • Help

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
France
Tel. +33 141318300
Fax +33 146318309
E-mail: vcparis@voisinconsulting.com

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

Decision