EMA/PE/0000183637 - paediatric investigation plan

humanised afucosylated IgG1 monoclonal antibody against CCR8

Key facts

• Active substance:
  humanised afucosylated IgG1 monoclonal antibody against CCR8
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000183637
• PIP number:
  EMA/PE/0000183637
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except melanoma, nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/03/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000183637 : EMA decision of 21 March 2025 on the granting of a product specific waiver for humanised afucosylated IgG1 monoclonal antibody against CCR8

Adopted Reference Number: EMADOC-1700519818-1974851