EMEA-002030-PIP01-16 - paediatric investigation plan

ambrisentan

Key facts

• Active Substance:
  ambrisentan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0038/2017
• PIP number:
  EMEA-002030-PIP01-16
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/01/2017

Decision

P/0038/2017: European Medicines Agency decision of 30 January 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for ambrisentan / tadalafil (EMEA-0020...

AdoptedReference Number: EMA/2910/2017