EMEA-000081-PIP01-07-M11 - paediatric investigation plan

dabigatran etexilate mesilate

Key facts

• Invented name:
  • Pradaxa
  • Pradaxa
• Active substance:
  dabigatran etexilate mesilate
• Therapeutic area:
  • Cardiovascular diseases
  • Haematology-Hemostaseology
• Decision number:
  P/0399/2018
• PIP number:
  EMEA-000081-PIP01-07-M11
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate dosage form, other
• Condition(s) / indication(s):
  • Prevention of thromboembolic events
  • Treatment of thromboembolic events
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/12/2018
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000081-PIP01-07-M11
• Compliance opinion date:
  23/08/2019
• Compliance outcome:
  Positive

Decision

P/0399/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate mesilate (Pradaxa) (EMEA-000081-PIP01-07-M11)

Adopted Reference Number: EMA/812162/2018