EMEA-003497-PIP01-23 - paediatric investigation plan

oregovomab

Key facts

• Active substance:
  oregovomab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0514/2023
• PIP number:
  EMEA-003497-PIP01-23
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  • Treatment of fallopian tube cancer
  • Treatment of ovarian cancer
  • Treatment of primary peritoneal cancer
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0514/2023 : EMA decision of 29 December 2023 on the granting of a product specific waiver for oregovomab (EMEA-003497-PIP01-23)

Reference Number: EMA/554788/2023