Bisoprolol fumarate / acetylsalicylic acid - paediatric investigation plan

Bisoprolol fumarate

acetylsalicylic acid

Key facts

• Active substance:
  • Bisoprolol fumarate
  • acetylsalicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/54/2009
• PIP number:
  Bisoprolol fumarate / acetylsalicylic acid
• Pharmaceutical form(s):
  Capsule
• Condition(s) / indication(s):
  • Angina pectoris
  • Essential hypertension
  • Secondary 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:
  24/03/2009
• Compliance check done:
  No

Decision

P/54/2009: European Medicines Agency decision of 24 March 2009 on the granting of a product specific waiver for bisoprolol fumarate / acetylsalicylic acid (EMEA-000449-PIP01-08) in accordance with Regulation (EC) No 1901...

Adopted Reference Number: EMEA/167372/2009