EMEA-000434-PIP01-08-M04

Key facts

Invented name
Volibris
Active substance
Ambrisentan
Therapeutic area
Cardiovascular diseases
Decision number
P/0322/2016
PIP number
EMEA-000434-PIP01-08-M04
Pharmaceutical form(s)
  • Film-coated tablets
  • dispersible tablets
Condition(s) / indication(s)
Pulmonary arterial hypertension
Route(s) of administration
Oral use
Contact for public enquiries
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 type
PM: decision on the application for modification of an agreed PIP

Decision

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