EMA/PE/0000235924 - paediatric investigation plan

Mitazalimab

Key facts

• Active substance:
  Mitazalimab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000235924
• PIP number:
  EMA/PE/0000235924
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of pancreatic cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000235924 : EMA decision of 16 May 2025 on the granting of a product specific waiver for mitazalimab

Adopted Reference Number: EMADOC-1700519818-2114084