MHRA-100439-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Asundexian
Invented Name
Not available at present
PIP Number MHRA-100439-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of arterial 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
23/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100439-PIP01-22-M01-C2

Decision Document

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