EMEA-002173-PIP01-17 - paediatric investigation plan

perindopril arginine

amlodipine

Bisoprolol fumarate

Key facts

• Active substance:
  • perindopril arginine
  • amlodipine
  • Bisoprolol fumarate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0290/2017
• PIP number:
  EMEA-002173-PIP01-17
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of hypertension
  • Treatment of ischaemic coronary artery disorders
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/10/2017
• Compliance check done:
  No

Decision

P/0290/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for bisoprolol (fumarate) / perindopril arginine / amlodipine (EMEA-002173-PIP01-17)

Adopted Reference Number: EMA/565635/2017