EMEA-002239-PIP01-17 - paediatric investigation plan

rosuvastatin calcium

acetylsalicylic acid

Key facts

• Active substance:
  • rosuvastatin calcium
  • acetylsalicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0039/2018
• PIP number:
  EMEA-002239-PIP01-17
• 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:
  16/02/2018
• Compliance check done:
  No

Decision

P/0039/2018: EMA decision of 16 February 2018 on the granting of a product specific waiver for rosuvastatin (calcium) / acetylsalicylic acid (EMEA- 002239-PIP01-17)

Reference Number: EMA/850787/2017