EMEA-000115-PIP02-09-M03

Key facts

Invented name
Translarna
Active substance
Ataluren
Therapeutic area
Pneumology-allergology
Decision number
P/0284/2016
PIP number
EMEA-000115-PIP02-09-M03
Pharmaceutical form(s)
Granules for oral suspension
Condition(s) / indication(s)
Treatment of cystic fibrosis
Route(s) of administration
Oral use
Contact for public enquiries
PTC Therapeutics International, Limited
France
Tel. +33 141318300
Fax +33 146318309
E-mail: vcparis@voisinconsulting.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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