EMEA-003410-PIP01-23 - paediatric investigation plan

acetylsalicylic acid

rosuvastatin calcium

Key facts

• Active substance:
  • acetylsalicylic acid
  • rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0266/2023
• PIP number:
  EMEA-003410-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0266/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for acetylsalicylic acid / rosuvastatin (calcium), (EMEA- 003410-PIP01-23)

Reference Number: EMA/250887/2023