EMEA-000480-PIP01-08-M14 - paediatric investigation plan

ticagrelor

Key facts

• Invented name:
  Brilique
• Active substance:
  ticagrelor
• Therapeutic area:
  • Cardiovascular diseases
  • Haematology-Hemostaseology
• Decision number:
  P/0175/2021
• PIP number:
  EMEA-000480-PIP01-08-M14
• Pharmaceutical form(s):
  • Film-coated tablet
  • Orodispersible tablet
  • Tablet
• Condition(s) / indication(s):
  Prevention of thromboembolic events
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/04/2021
• Compliance check done:
  Tá
• Compliance procedure number:
  EMEA-C-000480-PIP01-08-M14
• Compliance opinion date:
  25/06/2021
• Compliance outcome:
  Positive

Decision

P/0175/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (Brilique), (EMEA-000480-PIP01-08-M14)

Adopted Reference Number: EMA/197967/2021