EMEA-003376-PIP01-22 - paediatric investigation plan

recombinant humanized monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1κ) directed against integrin αvβ8 produced in Chinese Hamster Ovary (CHO) cells

Key facts

• Active substance:
  recombinant humanized monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1κ) directed against integrin αvβ8 produced in Chinese Hamster Ovary (CHO) cells
• Therapeutic area:
  Oncology
• Decision number:
  P/0180/2023
• PIP number:
  EMEA-003376-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of head and neck squamous cell carcinoma (HNSCC)
  • Treatment of renal cell carcinoma (RCC)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2024
• Compliance check done:
  No

Decision

P/0180/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for recombinant humanized monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1κ) ... (EMEA-003376-PIP01-22)

Reference Number: EMA/176012/2023