EMEA-002903-PIP03-21 - paediatric investigation plan

anti-C1s Humanized IgG4 Monoclonal Antibody

Key facts

• Active substance:
  anti-C1s Humanized IgG4 Monoclonal Antibody
• Therapeutic area:
  • Haematology-Hemostaseology
  • Immunology-Rheumatology-Transplantation
  • Neurology
• Decision number:
  P/0434/2021
• PIP number:
  EMEA-002903-PIP03-21
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0434/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for anti-C1s humanized IgG4 monoclonal antibody (EMEA-002903-PIP03-21)

Adopted Reference Number: P/0434/2021