EMEA-003469-PIP01-23 - paediatric investigation plan

Humanized IgG1 blocking monoclonal antibody targeting CD39 (IPH5201)

Key facts

• Active substance:
  Humanized IgG1 blocking monoclonal antibody targeting CD39 (IPH5201)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0494/2023
• PIP number:
  EMEA-003469-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer
• 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:
  01/12/2023
• Compliance check done:
  No

Decision

P/0494/2023: EMA decision of 1 December 2023 on the granting of a product specific waiver for humanized IgG1 blocking monoclonal antibody targeting CD39 (IPH5201), (EMEA-003469-PIP01-23)

Adopted Reference Number: EMA/517389/2023