EMEA-003071-PIP01-21 - paediatric investigation plan

Cedazuridine, decitabine

Key facts

• Active Substance:
  Cedazuridine, decitabine
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0217/2022
• PIP number:
  EMEA-003071-PIP01-21
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  • Gastric use
  • Oral use
• Contact for public enquiries:

  Otsuka Pharmaceutical Netherlands B.V.

  E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/06/2023

Decision

P/0217/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cedazuridine / decitabine (EMEA-003071-PIP01-21)

AdoptedReference Number: EMA/366238/2022