EMEA-002542-PIP03-20 - paediatric investigation plan

sutimlimab

Key facts

• Active Substance:
  sutimlimab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0146/2021
• PIP number:
  EMEA-002542-PIP03-20
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of cold agglutinin disease
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Genzyme Europe B.V.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2021

Decision

P/0146/2021: EMA decision of 14 April 2021 on the granting of a product specific waiver for sutimlimab (EMEA-002542-PIP03-20)

AdoptedReference Number: EMA/188461/2021