MHRA-100329-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • EDOXABAN TOSYLATE
Invented Name
  • Lixiana film-coated tablets
  • Lixiana
PIP Number MHRA-100329-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film coated tablets
  • Age-appropriate oral dosage form
Therapeutic area
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
Conditions / Indications
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EDOXABAN TOSYLATE.pdf
Published Date 07/12/2022