EMEA-002879-PIP01-20 - paediatric investigation plan

catumaxomab

Key facts

• Invented name:
  Remun
• Active substance:
  catumaxomab
• Therapeutic area:
  Oncology
• Decision number:
  P/0053/2021
• PIP number:
  EMEA-002879-PIP01-20
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of malignant ascites
• Route(s) of administration:
  Intraperitoneal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2021
• Compliance check done:
  No

Decision

P/0053/2021 : EMA decision of 27 January 2021 on the granting of a product specific waiver for catumaxomab (EMEA-002879-PIP01-20)

Adopted Reference Number: EMA/5045/2021