EMEA-003107-PIP01-21 - paediatric investigation plan

Gantenerumab

Key facts

• Active Substance:
  Gantenerumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0011/2022
• PIP number:
  EMEA-003107-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Prevention of Alzheimer's disease
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Roche Registration GmbH

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2022

Decision

P/0011/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for gantenerumab (EMEA-003107-PIP01-21)

Adopted