EMEA-000434-PIP01-08-M09 - paediatric investigation plan

ambrisentan

Key facts

• Invented name:
  Volibris
• Active Substance:
  ambrisentan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0428/2022
• PIP number:
  EMEA-000434-PIP01-08-M09
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Pulmonary arterial hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Glaxo Group Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022

Decision

P/0428/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M09)

AdoptedReference Number: EMA/826798/2022