EMEA-003046-PIP01-21 - paediatric investigation plan

Alnuctamab

Key facts

• Active Substance:
  Alnuctamab
• Therapeutic area:
  Oncology
• Decision number:
  P/0421/2021
• PIP number:
  EMEA-003046-PIP01-21
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of mature B cell malignancies
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2010

Decision

P/0421/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for alnuctamab, (EMEA-003046-PIP01-21)

AdoptedReference Number: EMA/532959/2021