EMEA-002239-PIP02-21 - paediatric investigation plan

Acetylsalicylic acid

rosuvastatin calcium

Key facts

• Active Substance:
  • Acetylsalicylic acid
  • rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0029/2022
• PIP number:
  EMEA-002239-PIP02-21
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Tel [phone]; Email: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2022

Decision

P/0029/2022: EMA of 31 January 2022 on the granting of a product specific waiver for acetylsalicylic acid / rosuvastatin calcium (EMEA-002239-PIP02-21)

Reference Number: EMA/12577/2022