EMEA-003275-PIP01-22 - paediatric investigation plan

namilumab

Key facts

• Active substance:
  namilumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0471/2022
• PIP number:
  EMEA-003275-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of sarcoidosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0471/2022: EMA decision of 1 December 2022 on the granting of a product specific waiver for namilumab (EMEA-003275-PIP01-22)

Adopted Reference Number: EMA/897866/2022