Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Protaphane   
Auth. number : EU/1/02/234
INN : Insulin human (rDNA)
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AC - Insulins and analogues for injection, intermediate-acting
Chemical substance: A10AC01 - Insulin (human)
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus.
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark

  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 continues to be 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
10/10/2002 Centralised - Authorisation EMEA/H/C/442 (2002)3796 of 07/10/2002
29/01/2003 Centralised - Variation EMEA/H/C/442/II/1
15/08/2003 Centralised - Variation EMEA/H/C/442/I/2 (2003)3055 of 13/08/2003
26/08/2003 Centralised - Variation EMEA/H/C/442/I/4 (2003)3145 of 22/08/2003
01/10/2003 Centralised - Variation EMEA/H/C/442/I/5
01/10/2003 Centralised - Variation EMEA/H/C/442/II/3
27/10/2003 Centralised - Variation EMEA/H/C/442/I/6
03/08/2004 Centralised - Variation EMEA/H/C/442/II/8
04/08/2004 Centralised - Variation EMEA/H/C/442/II/7 (2004)3040 of 02/08/2004
07/03/2005 Centralised - Variation EMEA/H/C/442/IA/11
Updated with Decision(2005)3790 of 05/10/2005
14/03/2005 Centralised - Variation EMEA/H/C/442/N/10
Updated with Decision(2005)3790 of 05/10/2005
24/05/2005 Centralised - Variation EMEA/H/C/442/IA/14
06/06/2005 Centralised - Variation EMEA/H/C/442/II/12
10/10/2005 Centralised - Variation (2005)3790 of 05/10/2005
25/04/2006 Centralised - Variation EMEA/H/C/442/IB/17
10/05/2006 Centralised - Variation EMEA/H/C/442/II/16
22/11/2006 Centralised - Variation EMEA/H/C/442/II/20
23/01/2007 Centralised - Variation EMEA/H/C/442/IA/24
27/02/2007 Centralised - Variation EMEA/H/C/442/II/21
27/02/2007 Centralised - Variation EMEA/H/C/442/II/23
03/05/2007 Centralised - Variation EMEA/H/C/442/II/25
05/07/2007 Centralised - Variation EMEA/H/C/442/IA/28
23/07/2007 Centralised - Variation EMEA/H/C/442/II/27
20/09/2007 Centralised - Renewal EMEA/H/C/442/R/26 (2007)4388 of 18/09/2007
21/11/2007 Centralised - Variation EMEA/H/C/442/II/29
18/03/2008 Centralised - Variation EMEA/H/C/442/N/31
Updated with Decision(2008)1749 of 25/04/2008
18/03/2008 Centralised - Variation EMEA/H/C/442/N/32
Updated with Decision(2008)1749 of 25/04/2008
29/04/2008 Centralised - Variation EMEA/H/C/442/II/30 (2008)1749 of 25/04/2008
05/06/2008 Centralised - Variation EMEA/H/C/442/II/34
07/07/2008 Centralised - Variation EMEA/H/C/442/IA/36
31/07/2008 Centralised - Variation EMEA/H/C/442/IA/37
19/09/2008 Centralised - Variation EMEA/H/C/442/N/35
Updated with Decision(2009)7657 of 01/10/2009
27/04/2009 Centralised - Variation EMEA/H/C/442/II/38
05/05/2009 Centralised - Variation EMEA/H/C/442/IA/39
07/07/2009 Centralised - Variation EMEA/H/C/442/IA/40
27/08/2009 Centralised - Variation EMEA/H/C/442/IA/41
Updated with Decision(2010)2949 of 29/04/2010
05/10/2009 Centralised - Variation EMEA/H/C/442/X/9 (2009)7657 of 01/10/2009
16/11/2009 Centralised - Variation EMEA/H/C/442/N/42
Updated with Decision(2010)2949 of 29/04/2010
21/12/2009 Centralised - Variation EMEA/H/C/442/IA/43
03/05/2010 Centralised - Variation (2010)2949 of 29/04/2010
16/08/2010 Centralised - Variation EMEA/H/C/442/IA/44
Updated with Decision(2011)1226 of 21/02/2011
25/02/2011 Centralised - Variation (2011)1226 of 21/02/2011
16/03/2011 Centralised - Variation EMEA/H/C/442/IG/48/G
22/03/2011 Centralised - Variation EMEA/H/C/442/WS/91 (2011)1886 of 17/03/2011
14/04/2011 Centralised - Variation EMEA/H/C/442/IA/45
Updated with Decision(2011)8063 of 03/11/2011
07/11/2011 Centralised - Variation (2011)8063 of 03/11/2011
02/07/2012 Centralised - Variation EMEA/H/C/442/II/50/G (2012)4513 of 27/06/2012
22/11/2012 Centralised - Variation EMEA/H/C/442/WS/273/G (2012)8583 of 19/11/2012
11/01/2013 Centralised - Variation EMEA/H/C/442/IG/251
Updated with Decision(2014)416 of 22/01/2014
24/01/2014 Centralised - Variation (2014)416 of 22/01/2014