EMEA-003226-PIP01-22 - paediatric investigation plan

nebivolol (hydrochloride)

Amlodipine besilate

Key facts

• Active Substance:
  • nebivolol (hydrochloride)
  • Amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0338/2022
• PIP number:
  EMEA-003226-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:
  10/08/2022

Decision

P/0338/2022 : EMA decision on the granting of a product specific waiver for nebivolol (hydrochloride) / amlodipine (besilate) (EMEA-003226-PIP01-22)

AdoptedReference Number: EMA/673867/2022