Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Regranex
Auth. number : EU/1/99/101
INN : becaplermin
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D03 - Preparations for treatment of wounds & ulcers
Pharmacological subgroup: D03A - Cicatrizants
Chemical subgroup: D03AX - Other cicatrizants
Chemical substance: D03AX06 - Becaplermin
(See WHO ATC Index)
Indication: REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
08/04/1999 Centralised - Authorisation EMEA/H/C/212 (1999)880 of 29/03/1999
29/07/1999 Centralised - Variation EMEA/H/C/212/I/1
14/04/2000 Centralised - Variation EMEA/H/C/212/I/3
28/04/2000 Centralised - Variation EMEA/H/C/212/I/2
13/03/2001 Centralised - Variation EMEA/H/C/212/II/4
04/07/2001 Centralised - Variation EMEA/H/C/212/II/5
15/02/2002 Centralised - Variation EMEA/H/C/212/I/6
26/08/2002 Centralised - Variation EMEA/H/C/212/II/7 (2002)3189 of 22/08/2002
10/09/2002 Centralised - Variation EMEA/H/C/212/I/9
10/09/2002 Centralised - Variation EMEA/H/C/212/I/10
10/09/2002 Centralised - Variation EMEA/H/C/212/I/8
02/05/2003 Centralised - Variation EMEA/H/C/212/II/11
25/07/2003 Centralised - Variation EMEA/H/C/212/N/12 (2003)2778 of 23/07/2003
02/10/2003 Centralised - Variation EMEA/H/C/212/II/13
02/04/2004 Centralised - Renewal EMEA/H/C/212/R/14 (2004)1325 of 31/03/2004
10/08/2005 Centralised - Variation EMEA/H/C/212/II/16
10/08/2005 Centralised - Variation EMEA/H/C/212/II/15
20/09/2005 Centralised - Variation EMEA/H/C/212/N/17
Updated with Decision(2005)6017 of 23/12/2005
02/01/2006 Centralised - Variation EMEA/H/C/212/II/18 (2005)6017 of 23/12/2005
29/03/2006 Centralised - Variation EMEA/H/C/212/N/19
Updated with Decision(2009)241 of 16/01/2009
12/04/2006 Centralised - Variation EMEA/H/C/212/IA/22
12/04/2006 Centralised - Variation EMEA/H/C/212/IA/21
23/06/2006 Centralised - Variation EMEA/H/C/212/IA/23
04/07/2006 Centralised - Variation EMEA/H/C/212/II/20
15/08/2006 Centralised - Variation EMEA/H/C/212/N/24
Updated with Decision(2009)241 of 16/01/2009
03/08/2007 Centralised - Variation EMEA/H/C/212/N/25
Updated with Decision(2009)241 of 16/01/2009
05/12/2007 Centralised - Variation EMEA/H/C/212/N/26
Updated with Decision(2009)241 of 16/01/2009
12/06/2008 Centralised - Variation EMEA/H/C/212/IA/28
Updated with Decision(2009)241 of 16/01/2009
15/07/2008 Centralised - Variation EMEA/H/C/212/IA/30
Updated with Decision(2009)241 of 16/01/2009
24/07/2008 Centralised - Variation EMEA/H/C/212/IB/29
20/01/2009 Centralised - Variation (2009)241 of 16/01/2009
23/03/2009 Centralised - Renewal EMEA/H/C/212/R/31 (2009)2124 of 19/03/2009
24/11/2009 Centralised - Variation EMEA/H/C/212/II/34 (2009)9340 of 20/11/2009
30/06/2010 Centralised - Variation EMEA/H/C/212/II/36
06/09/2010 Referral EMEA/H/C/212/A-20/33 (2010)6138 of 01/09/2010
12/10/2010 Centralised - Variation EMEA/H/C/212/IB/37/G
Updated with Decision(2011)557 of 27/01/2011
31/01/2011 Centralised - Variation (2011)557 of 27/01/2011
18/07/2012 Centralised - Withdrawal (2012)5091 of 16/07/2012