EMEA-003100-PIP01-21 - paediatric investigation plan

Humanized monoclonal antibody of IgG1 subtype targeting NRP1

Key facts

• Active Substance:
  Humanized monoclonal antibody of IgG1 subtype targeting NRP1
• Therapeutic area:
  Neurology
• Decision number:
  P/0522/2022
• PIP number:
  EMEA-003100-PIP01-21
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2022

Decision

P/0522/2022: EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanized monoclonal IgG1-based antibody (RO7204239) (EMEA-003100- PIP01-21)

AdoptedReference Number: EMA/929802/2022