EMEA-002891-PIP01-20 - paediatric investigation plan

rosuvastatin calcium

Acetylsalicylic acid

Key facts

• Active Substance:
  • rosuvastatin calcium
  • Acetylsalicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0045/2021
• PIP number:
  EMEA-002891-PIP01-20
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Neopharmed Gentili S.p.A.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2021

Decision

P/0045/2021 : EMA decision of 27 January 2021 on the granting of a product specific waiver for rosuvastatin (calcium) / acetylsalicylic acid (EMEA- 002891-PIP01-20)

AdoptedReference Number: EMA/18944/2021