EMEA-003071-PIP02-23 - paediatric investigation plan

EMEA-003071-PIP02-23 - paediatric investigation plan cedazuridine decitabine PIP Human 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 Contact for public enquiries Otsuka Pharmaceutical Netherlands B.V. E-mail: communications@otsuka-europe.com Tel. +44 2037475001 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 No 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 English (EN) (208.17 KB - PDF) First published: 13/02/2025 View Related content Decitabine, cedazuridine : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision English (EN) (83.9 KB - PDF) First published: 10/04/2026 View Share this page