EMEA-000631-PIP01-09 - paediatric investigation plan

simvastatin

ramipril

acetyl salicylic acid

Key facts

• Active substance:
  • simvastatin
  • ramipril
  • acetyl salicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/235/2009
• PIP number:
  EMEA-000631-PIP01-09
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Prevention of Ischaemic Heart Disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/11/2009
• Compliance check done:
  No

Decision

P/235/2009: European Medicines Agency Decision of 27 November 2009 on the granting of a product specific waiver for simvastatin / ramipril / acetyl salicylic acid (EMEA-000631-PIP01-09) in accordance with Regulation (EC)...

Adopted Reference Number: EMEA/748470/2009