EMEA-003015-PIP01-21 - paediatric investigation plan

Indapamide

perindopril arginine

amlodipine

bisoprolol (fumarate)

Key facts

• Active substance:
  • Indapamide
  • perindopril arginine
  • amlodipine
  • bisoprolol (fumarate)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0366/2021
• PIP number:
  EMEA-003015-PIP01-21
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  08/09/2021
• Compliance check done:
  No

Decision

P/0366/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for indapamide / perindopril (arginine) / amlodipine / bisoprolol (fumarate) (EMEA-003015-PIP01-21)

Adopted Reference Number: EMA/440421/2021