EMEA-000183-PIP01-08-M08 - paediatric investigation plan

Apixaban

Key facts

• Invented name:
  • Eliquis
  • Eliquis
• Active Substance:
  Apixaban
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0198/2020
• PIP number:
  EMEA-000183-PIP01-08-M08
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral liquid dosage form
  • Age-appropriate dosage form, other
• Condition(s) / indication(s):
  • Prevention of arterial thromboembolism
  • Prevention of venous thromboembolism
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bristol-Myers Squibb Pharma EEIG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/05/2020
• Compliance procedure number:
  EMEA-C-000183-PIP01-08-M08
• Compliance opinion date:
  24/06/2022
• Compliance outcome:
  Positive

Decision

P/0198/2020: EMA decision of 20 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis), (EMEA-000183-PIP01-08-M08)

AdoptedReference Number: EMA/266985/2020