MHRA-100558-PIP01-22

Key Facts

Active Substance
Active Substance:
  • milvexian
Invented Name
Not available at present
PIP Number MHRA-100558-PIP01-22
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of thromboembolism in patients with cardiovascular disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):milvexian.pdf
Published Date 30/04/2024