EMEA-001516-PIP01-13 - paediatric investigation plan

Enalapril (maleate)

Key facts

• Active substance:
  Enalapril (maleate)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0112/2014
• PIP number:
  EMEA-001516-PIP01-13
• Pharmaceutical form(s):
  • Tablet for oral suspension
  • Orodispersible film
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  05/05/2014
• Compliance check done:
  No

Decision

P/0112/2014: EMA decision of 5 May 2014 on the agreement of a paediatric investigation plan and on the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13)

Adopted Reference Number: EMA/235549/2014