EMEA-002499-PIP03-24 - paediatric investigation plan

tafasitamab

Key facts

• Invented name:
  Minjuvi
• Active substance:
  tafasitamab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0344/2024
• PIP number:
  EMEA-002499-PIP03-24
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms excluding diffuse large B-cell lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0344/2024 : EMA decision of 13 September 2024 on the granting of a product specific waiver for tafasitamab (Minjuvi), (EMEA-002499-PIP03-24)

Adopted Reference Number: EMA/415176/2024