EMEA-002274-PIP01-17 - paediatric investigation plan

trandolapril

Key facts

• Active substance:
  trandolapril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0192/2018
• PIP number:
  EMEA-002274-PIP01-17
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  17/07/2018
• Compliance check done:
  No

Decision

P/0192/2018: EMA decision of 17 July 2018 on the refusal of a product specific waiver for trandolapril (EMEA-002274-PIP01-17)

Adopted Reference Number: EMA/378944/2018