EMEA-001272-PIP02-13-M01

Adopted

First published: 23/11/2015
Last updated: 23/11/2015
EMA/578620/2015

Invented name	Vidaza
Active substance	azacitidine
Therapeutic area	Haematology-Hemostaseology
Decision number	P/0217/2015
PIP number	EMEA-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 administration	Subcutaneous use Intravenous use
Contact for public enquiries	Celgene Europe Ltd Switzerland Tel. +41 3272 98500 Fax +41 3272 98508 E-mail: medinfo.intl@celgene.com
Decision type	PM: decision on the application for modification of an agreed PIP