EMEA-003430-PIP01-23 - paediatric investigation plan

ramipril

nebivolol (hydrochloride)

Key facts

• Active substance:
  • ramipril
  • nebivolol (hydrochloride)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0343/2023
• PIP number:
  EMEA-003430-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of 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:
  08/09/2023
• Compliance check done:
  No

Decision

P/0343/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for ramipril / nebivolol (hydrochloride) (EMEA-003430- PIP01-23)

Adopted Reference Number: EMA/352008/2023