EMEA-003227-PIP01-22 - paediatric investigation plan

nebivolol (hydrochloride)

Key facts

• Active substance:
  nebivolol (hydrochloride)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0276/2022
• PIP number:
  EMEA-003227-PIP01-22
• 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:
  11/08/2023
• Compliance check done:
  No

Decision

P/0276/2022 : EMA decision on the granting of a product specific waiver for nebivolol (as nebivolol hydrochloride) / valsartan (EMEA-003227-PIP01-22)

Adopted Reference Number: EMA/665980/2022