Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Apidra   
Auth. number : EU/1/04/285
INN : Insulin glulisine
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AB - Insulins and analogues for injection, fast-acting
Chemical substance: A10AB06 - Insulin glulisine
(See WHO ATC Index)
Indication: Treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required
Marketing Authorisation Holder: Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland

  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
29/09/2004 Centralised - Authorisation EMEA/H/C/557 (2004)3653 of 27/09/2004
16/03/2005 Centralised - Variation EMEA/H/C/557/N/3
Updated with Decision(2005)1521 of 13/05/2005
23/03/2005 Centralised - Variation EMEA/H/C/557/II/1
18/05/2005 Centralised - Variation EMEA/H/C/557/II/2 (2005)1521 of 13/05/2005
06/07/2005 Centralised - Variation EMEA/H/C/557/II/4 (2005)2567 of 04/07/2005
16/09/2005 Centralised - Variation EMEA/H/C/557/N/6
Updated with Decision(2006)1957 of 05/05/2006
19/10/2005 Centralised - Variation EMEA/H/C/557/II/5
06/03/2006 Centralised - Variation EMEA/H/C/557/IA/9
Updated with Decision(2006)1957 of 05/05/2006
11/05/2006 Centralised - Variation EMEA/H/C/557/II/8 (2006)1957 of 05/05/2006
01/08/2006 Centralised - Variation EMEA/H/C/557/IB/11
07/09/2006 Centralised - Variation EMEA/H/C/557/II/10 (2006)4014 of 01/09/2006
26/10/2006 Centralised - Variation EMEA/H/C/557/II/12 (2006)5181 of 24/10/2006
06/12/2006 Centralised - Variation EMEA/H/C/557/IB/13
29/03/2007 Centralised - Variation EMEA/H/C/557/N/14
Updated with Decision(2007)3302 of 02/07/2007
25/06/2007 Centralised - Variation EMEA/H/C/557/II/16
05/07/2007 Centralised - Variation EMEA/H/C/557/II/15 (2007)3302 of 02/07/2007
06/08/2007 Centralised - Variation EMEA/H/C/557/IA/18
21/02/2008 Centralised - Variation EMEA/H/C/557/IB/20
24/06/2008 Centralised - Variation EMEA/H/C/557/II/17, 19 (2008)3150 of 20/06/2008
21/01/2009 Centralised - Variation EMEA/H/C/557/IA/24
17/02/2009 Centralised - Variation EMEA/H/C/557/IB/22
19/03/2009 Centralised - Variation EMEA/H/C/557/N/21
Updated with Decision(2009)6581 of 20/08/2009
24/08/2009 Centralised - Renewal EMEA/H/C/557/R/25 (2009)6581 of 20/08/2009
11/11/2009 Centralised - Variation EMEA/H/C/557/IB/27
11/11/2009 Centralised - Variation EMEA/H/C/557/IB/27
14/01/2010 Centralised - Variation EMEA/H/C/557/X/23 (2010)119 of 12/01/2010
27/05/2010 Centralised - Variation EMEA/H/C/557/IA/4G
Updated with Decision(2010)6239 of 06/09/2010
09/09/2010 Centralised - Variation (2010)6239 of 06/09/2010
17/09/2010 Centralised - Variation EMEA/H/C/557/IA/30
01/11/2010 Centralised - Variation EMEA/H/C/557/IB/32
02/12/2010 Centralised - Variation EMEA/H/C/557/IB/31
Updated with Decision(2011)471 of 24/01/2011
20/12/2010 Centralised - Variation EMEA/H/C/557/IA/33
19/01/2011 Centralised - Variation EMEA/H/C/557/IB/34
Updated with Decision(2011)6369 of 05/09/2011
27/01/2011 Centralised - Variation EMEA/H/C/557/II/29 (2011)471 of 24/01/2011
07/09/2011 Centralised - Variation (2011)6369 of 05/09/2011
26/04/2012 Centralised - Variation EMEA/H/C/557/WS/208 (2012)2862 of 20/04/2012
23/11/2012 Centralised - Variation EMEA/H/C/557/II/47 (2012)8598 of 19/11/2012
17/09/2013 Centralised - Variation EMEA/H/C/557/IB/52
24/10/2013 Centralised - Variation EMEA/H/C/557/II/49
22/11/2013 Centralised - Variation EMEA/H/C/557/IB/53
06/05/2014 Centralised - Variation EMEA/H/C/557/N/56