Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Telzir   
Auth. number : EU/1/04/282
INN : Fosamprenavir
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: J05AE - Protease inhibitors
Chemical substance: J05AE07 - Fosamprenavir
(See WHO ATC Index)
Indication: Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents.
In heavily pretreated patients the use of Telzir in combination with low dose ritonavir has not been sufficiently studied.In protease inhibitor (PI) experienced patients the choice of Telzir should be based on individual viral resistance testing and treatment history.
Marketing Authorisation Holder: ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, 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
14/07/2004 Centralised - Authorisation EMEA/H/C/534 (2004)2786 of 12/07/2004
22/12/2004 Centralised - Variation EMEA/H/C/534/II/1 (2004)5382 of 17/12/2004
10/08/2005 Centralised - Variation EMEA/H/C/534/IB/4
26/08/2005 Centralised - Variation EMEA/H/C/534/II/2 (2005)3283 of 24/08/2005
27/10/2005 Centralised - Variation EMEA/H/C/534/II/3 (2005)4260 of 25/10/2005
16/12/2005 Centralised - Variation EMEA/H/C/534/IB/6
02/03/2006 Centralised - Variation EMEA/H/C/534/II/5 (2006)699 of 28/02/2006
20/04/2006 Centralised - Variation EMEA/H/C/534/IA/13, 14 (2006)1689 of 18/04/2006
27/10/2006 Centralised - Variation EMEA/H/C/534/IA/13/14
07/11/2006 Centralised - Variation EMEA/H/C/534/II/10, 11 (2006)5371 of 31/10/2006
10/11/2006 Centralised - Variation EMEA/H/C/534/IB/16
10/11/2006 Centralised - Variation EMEA/H/C/534/IB/15
08/01/2007 Centralised - Variation EMEA/H/C/534/IA/19
09/01/2007 Centralised - Variation EMEA/H/C/534/II/12 (2007)20 of 03/01/2007
22/01/2007 Centralised - Variation EMEA/H/C/534/II/8, 17 (2007)192 of 18/01/2007
02/03/2007 Centralised - Variation EMEA/H/C/534/II/9 (2007)740 of 28/02/2007
12/06/2007 Centralised - Variation EMEA/H/C/534/IA/23, 24, 25, 26
05/07/2007 Centralised - Variation EMEA/H/C/534/II/20 (2007)3304 of 02/07/2007
09/07/2007 Centralised - Variation EMEA/H/C/534/IB/22
09/07/2007 Centralised - Variation EMEA/H/C/534/IB/22
26/07/2007 Centralised - Variation EMEA/H/C/534/II/21 (2007)3645 of 24/07/2007
08/08/2007 Centralised - Variation EMEA/H/C/534/IB/29
17/09/2007 Centralised - Variation EMEA/H/C/534/IA/30
Updated with Decision(2007)5275 of 23/10/2007
18/09/2007 Centralised - Variation EMEA/H/C/534/II/18 (2007)4305 of 13/09/2007
25/10/2007 Centralised - Variation EMEA/H/C/534/II/27 (2007)5275 of 23/10/2007
23/11/2007 Centralised - Variation EMEA/H/C/534/II/28 (2007)5742 of 21/11/2007
22/01/2008 Centralised - Variation EMEA/H/C/534/II/31 (2008)301 of 18/01/2008
03/03/2008 Centralised - Variation EMEA/H/C/534/II/32 (2008)842 of 28/02/2008
24/06/2008 Centralised - Variation EMEA/H/C/531/II/33, 34 (2008)3199 of 20/06/2008
09/07/2008 Centralised - Variation EMEA/H/C/534/II/35 (2008)3563 of 07/07/2008
31/07/2008 Centralised - Variation EMEA/H/C/534/II/36 (2008)4167 of 29/07/2008
23/10/2008 Centralised - Variation EMEA/H/C/534/II/37 (2008)6249 of 21/10/2008
24/12/2008 Centralised - Variation EMEA/H/C/534/II/38 (2008)8970 of 22/12/2008
02/03/2009 Centralised - Variation EMEA/H/C/534/II/40 (2009)1461 of 26/02/2009
27/03/2009 Centralised - Variation EMEA/H/C/534/II/41, 42 (2009)2311 of 25/03/2009
20/05/2009 Centralised - Renewal EMEA/H/C/534/R/43 (2009)4045 of 15/05/2009
18/09/2009 Centralised - Variation EMEA/H/C/534/IA/47
29/09/2009 Centralised - Variation EMEA/H/C/534/II/45
25/11/2009 Centralised - Variation EMEA/H/C/534/II/39, 44 (2009)9450 of 23/11/2009
22/01/2010 Centralised - Variation EMEA/H/C/534/II/48 (2010)406 of 20/01/2010
11/05/2010 Centralised - Variation EMEA/H/C/534/IB/51
Updated with Decision(2010)6024 of 26/08/2010
28/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/534/T/50 (2010)3493 of 26/05/2010
13/07/2010 Centralised - Variation EMEA/H/C/534/IB/52
Updated with Decision(2010)6024 of 26/08/2010
31/08/2010 Centralised - Variation EMEA/H/C/534/II/53 (2010)6024 of 26/08/2010
25/10/2010 Centralised - Variation EMEA/H/C/534/IB/54
Updated with Decision(2011)2855 of 18/04/2011
10/11/2010 Centralised - Variation EMEA/H/C/534/IB/55/G
10/11/2010 Centralised - Variation EMEA/H/C/534/IB/56/G
28/03/2011 Centralised - Variation EMEA/H/C/534/IA/59
Updated with Decision(2011)3722 of 23/05/2011
12/04/2011 Centralised - Variation EMEA/H/C/534/IA/60/G
Updated with Decision(2011)3722 of 23/05/2011
21/04/2011 Centralised - Variation EMEA/H/C/534/II/58 (2011)2855 of 18/04/2011
26/05/2011 Centralised - Variation EMEA/H/C/534/II/57 (2011)3722 of 23/05/2011
28/09/2011 Centralised - Variation EMEA/H/C/534/IA/62
Updated with Decision(2012)2410 of 04/04/2012
11/04/2012 Centralised - Variation (2012)2410 of 04/04/2012
26/10/2012 Centralised - Variation EMEA/H/C/534/II/67 (2012)7610 of 23/10/2012
15/11/2012 Centralised - Variation EMEA/H/C/534/II/68
Updated with Decision(2013)1898 of 26/03/2013
21/02/2013 Centralised - Variation EMEA/H/C/534/II/66
Updated with Decision(2013)1898 of 26/03/2013
28/03/2013 Centralised - Variation EMEA/H/C/534/WS/338/70 (2013)1898 of 26/03/2013
22/11/2013 Centralised - Variation EMEA/H/C/534/IB/73 (2013)8329 of 20/11/2013
25/04/2014 Centralised - Variation EMEA/H/C/534/WS/655
25/04/2014 Centralised - Variation EMEA/H/C/534/II/74