Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: DepoCyte   
Auth. number : EU/1/01/187
Active substance : Cytarabine
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC01 - Cytarabine
(See WHO ATC Index)
Indication: Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Marketing Authorisation Holder: Pacira Limited
3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/07/2001 Centralised - Authorisation EMEA/H/C/317 (2001)1998 of 11/07/2001
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/I/2, 3, 4
15/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/1
10/03/2004 Centralised - Notification EMEA/H/C/317/N/5 (2004)809 of 08/03/2004
11/05/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/7
02/06/2004 Centralised - Variation EMEA/H/C/317/IB/6
Updated with Decision(2005)1600 of 23/05/2005
25/05/2005 Centralised - Variation (2005)1600 of 23/05/2005
02/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/II/9
22/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/II/11
31/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/II/12
21/02/2006 Centralised - Variation EMEA/H/C/317/IA/14
Updated with Decision(2006)2891 of 19/06/2006
21/06/2006 Centralised - Renewal EMEA/H/C/317/R/13 (2006)2891 of 19/06/2006
07/09/2006 Corrigendum EMEA/H/C/317/R/13
04/10/2006 Centralised - Notification EMEA/H/C/317/N/15
Updated with Decision(2007)68 of 08/01/2007
17/11/2006 Centralised - Notification EMEA/H/C/317/N/17
Updated with Decision(2007)68 of 08/01/2007
10/01/2007 Centralised - Variation EMEA/H/C/317/II/16 (2007)68 of 08/01/2007
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/21
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/22
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/20
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/23
27/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/25
10/01/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/317/T/26 (2008)31 of 08/01/2008
14/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/27
14/03/2008 Centralised - Variation EMEA/H/C/317/IA/28
Updated with Decision(2008)6095 of 14/10/2008
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/30
15/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IB/29
16/10/2008 Centralised - Variation (2008)6095 of 14/10/2008
25/03/2009 Centralised - Variation EMEA/H/C/317/IA/32
Updated with Decision(2009)4327 of 28/05/2009
01/06/2009 Centralised - Variation EMEA/H/C/317/II/31 (2009)4327 of 28/05/2009
30/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/II/33
20/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/II/34
18/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IB/36
18/05/2010 Centralised - Variation EMEA/H/C/317/IA/37
Updated with Decision(2010)8666 of 29/11/2010
08/06/2010 Centralised - Variation EMEA/H/C/317/II/35 (2010)3707 of 04/06/2010
19/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/317/IA/38/G
18/01/2011 Centralised - Variation (2010)8666 of 29/11/2010
20/05/2011 Centralised - Renewal EMEA/H/C/317/R/39 (2011)3593 of 18/05/2011
12/07/2011 Centralised - Notification EMEA/H/C/317/N/40
22/11/2012 Centralised - Notification EMEA/H/C/317/N/43
20/05/2015 Centralised - Variation EMEA/H/C/317/IB/52/G