EMEA-002903-PIP02-21 - 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/0252/2021
• PIP number:
  EMEA-002903-PIP02-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of cold agglutinin disease
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/07/2021
• Compliance check done:
  No

Decision

P/0252/2021: EMA decision of 9 July 2021 on the granting of a product specific waiver for anti-C1s humanized IgG4 monoclonal antibody (EMEA- 002903-PIP02-21)

Reference Number: EMA/358148/2021