EMEA-003206-PIP01-22 - paediatric investigation plan

Acetylsalicylic acid

rosuvastatin calcium

Key facts

• Active Substance:
  • Acetylsalicylic acid
  • rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0281/2022
• PIP number:
  EMEA-003206-PIP01-22
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  CIPROS S.r.l.

  email: [e-mail]; tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2023

Decision

P/0281/2022 : EMA decision on 11 August 2022 on the granting of a product specific waiver for rosuvastatin (calcium) / acetylsalicylic acid (EMEA- 003206-PIP01-22)

AdoptedReference Number: EMA/629011/2022