EMEA-003146-PIP01-21 - paediatric investigation plan

acetylsalicylic acid

ticagrelor

Key facts

• Active substance:
  • acetylsalicylic acid
  • ticagrelor
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0113/2022
• PIP number:
  EMEA-003146-PIP01-21
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Prevention of atherothrombotic 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:
  13/04/2022
• Compliance check done:
  No

Decision

P/0113/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for acetylsalicylic acid / ticagrelor (EMEA-003146-PIP01- 21)

Adopted Reference Number: EMA/148949/2022