Amlodipine besilate / bisoprolol fumarate - paediatric investigation plan

amlodipine besilate

Bisoprolol fumarate

Key facts

• Active substance:
  • amlodipine besilate
  • Bisoprolol fumarate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/251/2009
• PIP number:
  Amlodipine besilate / bisoprolol fumarate
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Chronic stable angina pectoris
  • 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:
  18/12/2009
• Compliance check done:
  Nej

Decision

P/251/2009: EMA decision of 18 December 2009 on the granting of a product specific waiver for amlodipine besilate / bisoprolol fumarate (EMEA-000657-PIP01-09) in accordance with Regulation (EC) No ...

Adopted Reference Number: EMA/817473/2009