MHRA-102105-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Trontinemab
Invented Name
Trontinemab
PIP Number MHRA-102105-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Alzheimer's disease
Route(s) of administration
Route(s) of administration:
  • All routes of administration
PIP applicant
  • Roche Products Ltd
  • Country United Kingdom
  • Tel 01707368671
  • Email uk.dra@roche.com
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):Trontinemab.pdf
Published Date 17/12/2025