MHRA-100309-PIP01-21

Key Facts

Active Substance
Active Substance:
  • gantenerumab
Invented Name
Not available at present
PIP Number MHRA-100309-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Prevention of Alzheimer's disease
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 07824821881
  • 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):gantenerumab.pdf
Published Date 19/05/2022