Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fuzeon   
Auth. number : EU/1/03/252
Active substance : Enfuvirtide
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AX - Other antivirals
Chemical substance: J05AX07 - Enfuvirtide
(See WHO ATC Index)
Indication: Treatment of HIV-1infected patients
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1).
In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate (see sections 4.4 and 5.1).
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
29/05/2003 Centralised - Authorisation EMEA/H/C/514 (2003)1806 of 27/05/2003
30/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/I/1
28/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/IA/3
02/02/2004 Centralised - Variation EMEA/H/C/514/IA/4
Updated with Decision(2004)2084 of 08/06/2004
31/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/II/2
10/06/2004 Centralised - Variation EMEA/H/C/514/II/5 (2004)2084 of 08/06/2004
21/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/IA/7
20/10/2004 Centralised - Annual reassessment EMEA/H/C/514/S/6 (2004)4125 of 15/10/2004
03/12/2004 Centralised - Variation EMEA/H/C/514/IB/10
Updated with Decision(2005)1187 of 11/04/2005
22/12/2004 Centralised - Variation EMEA/H/C/514/II/11 (2004)5393 of 17/12/2004
22/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/II/9
22/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/II/8
13/04/2005 Centralised - Variation EMEA/H/C/514/II/12 (2005)1187 of 11/04/2005
07/10/2005 Centralised - Annual reassessment EMEA/H/C/514/S/13 (2005)3798 of 05/10/2005
12/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/IA/16
14/12/2005 Centralised - Variation EMEA/H/C/514/IA/14
Updated with Decision(2006)3390 of 20/07/2006
14/12/2005 Centralised - Variation EMEA/H/C/514/IA/15
Updated with Decision(2006)3390 of 20/07/2006
26/07/2006 Centralised - Variation (2006)3390 of 20/07/2006
25/09/2006 Centralised - Annual reassessment EMEA/H/C/514/S/18 (2006)4295 of 21/09/2006
26/10/2006 Centralised - Variation EMEA/H/C/514/II/17 (2006)5182 of 24/10/2006
26/01/2007 Centralised - Variation EMEA/H/C/514/II/19 (2007)257 of 24/01/2007
19/04/2007 Centralised - Variation EMEA/H/C/514/IA/21
Updated with Decision(2007)4158 of 30/08/2007
22/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/II/20
05/09/2007 Centralised - Variation EMEA/H/C/514/II/22 (2007)4158 of 30/08/2007
05/09/2007 Centralised - Variation EMEA/H/C/514/II/22 (2007)4158 of 30/08/2007
04/10/2007 Centralised - Annual reassessment EMEA/H/C/514/S/23 (2007)4601 of 02/10/2007
07/11/2007 Centralised - Variation EMEA/H/C/514/II/24 (2007)5428 of 31/10/2007
12/11/2007 Corrigendum EMEA/H/C/514/II/22 (2007)4158 cor of 08/11/2007
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/II/25
10/07/2008 Centralised - Renewal EMEA/H/C/514/R/26 (2008)3602 of 08/07/2008
21/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/IA/27
15/10/2008 Corrigendum EMEA/H/C/514/R/26 (2008)6046 cor of 13/10/2008
06/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/IB/28
12/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/514/IB/29
13/01/2010 Centralised - Variation EMEA/H/C/514/IB/30
Updated with Decision(2010)1970 of 22/03/2010
24/03/2010 Centralised - Variation (2010)1970 of 22/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/514/II/31 (2010)2837 of 27/04/2010
29/10/2012 Centralised - Notification EMEA/H/C/514/N/35
Updated with Decision(2014)4852 of 04/07/2014
28/05/2013 Centralised - Variation EMEA/H/C/514/IB/38
Updated with Decision(2014)4852 of 04/07/2014
14/06/2013 Centralised - Variation EMEA/H/C/514/IB/39/G
Updated with Decision(2014)4852 of 04/07/2014
20/03/2014 Centralised - Variation EMEA/H/C/514/II/41
Updated with Decision(2014)4852 of 04/07/2014
08/07/2014 Centralised - Yearly update (2014)4852 of 04/07/2014
18/12/2015 PSUSA - Modification EMEA/H/C/514/PSUSA/1217/201503 (2015)9643 of 16/12/2015