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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Telzir
|
| Auth. number : | EU/1/04/282 |
| INN : | Fosamprenavir |
| ATC: | J - General antiinfectives for systemic use J05 - Antivirals for systemic use J05A - Agents affecting the virus directly J05AE - Protease inhibitors 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| 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 |