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
Yes
Compliance Check Decision Date
Compliance opinion date
02/11/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100329-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EDOXABAN TOSYLATE.pdf
Published Date 01/05/2026