EMEA-003071-PIP02-23 - paediatric investigation plan

cedazuridine

decitabine

Key facts

• Active substance:
  • cedazuridine
  • decitabine
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0543/2023
• PIP number:
  EMEA-003071-PIP02-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of myelodysplastic syndromes, including juvenile myelomonocytic leukaemia
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  21/12/2023
• Compliance check done:
  Nie

Decision

P/0543/2023: EMA decision of 21 December 2023 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-PIP02-23)

Reference Number: EMA/564095/2023