EMEA-000434-PIP01-08-M04

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Overview

Product details for Volibris
Invented nameVolibris
Active substance

Ambrisentan

Decision numberP/0322/2016
PIP numberEMEA-000434-PIP01-08-M04
Pharmaceutical form(s)Film-coated tablets; dispersible tablets
Condition(s)/indication(s)

Pulmonary arterial hypertension

Route(s) of administrationOral use
PIP applicant

Glaxo Group Limited
United Kingdom
Tel. +44 (0)20 8990 3650
Fax +44 (0)20 8990 3511
E-mail: eu.paediatric-plans@gsk.com

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

Decision