MHRA-102076-PIP01-25

Key Facts

Active Substance
Active Substance:
  • EMICIZUMAB
Invented Name
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
PIP Number MHRA-102076-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of von Willebrand Disease.
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 07776566386
  • Email uk.dra@roche.com
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):EMICIZUMAB.pdf
Published Date 18/12/2025