EMEA-001272-PIP02-13-M01

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Overview

Product details for Vidaza
Invented nameVidaza
Active substance

Azacitidine

Decision numberP/0217/2015
PIP numberEMEA-001272-PIP02-13-M01
Pharmaceutical form(s)Powder for suspension for injection, Powder for solution for infusion
Condition(s)/indication(s)

Treatment of myelodysplastic syndrome (including juvenile myelomonocytic leukaemia)

Treatment of acute myeloid leukaemia

Route(s) of administrationSubcutaneous use, Intravenous use
PIP applicant

Celgene Europe Ltd
Switzerland
Tel. +41 3272 98500
Fax +41 3272 98508
E-mail: medinfo.intl@celgene.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision