EMEA-002768-PIP01-20 - paediatric investigation plan

Bisoprolol fumarate

trimetazidine (dihydrochloride)

Key facts

• Active substance:
  • Bisoprolol fumarate
  • trimetazidine (dihydrochloride)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0261/2020
• PIP number:
  EMEA-002768-PIP01-20
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  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:
  17/07/2020
• Compliance check done:
  No

Decision

P/0261/2020: EMA decision of 17 July 2020 on the granting of a product specific waiver for bisoprolol (fumarate) / trimetazidine (dihydrochloride) (EMEA-002768-PIP01-20)

Adopted Reference Number: EMA/366694/2020