Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Agenerase
Auth. number : EU/1/00/148
Active substance : amprenavir
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: J05AE05 - Amprenavir
(See WHO ATC Index)
Indication: Treatment of protease inhibitor experienced HIV-1 infected adults and children above th eage of 4 years, in combination with other antiretroviral agents.
Marketing Authorisation Holder: Glaxo Group Limited
Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, 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
23/10/2000 Centralised - Authorisation EMEA/H/C/264 (2000)2853 of 20/10/2000
10/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/V/1
25/10/2001 Centralised - Variation EMEA/H/C/264/II/2 (2001)2974 of 24/10/2001
26/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/I/8, 9
22/05/2002 Centralised - Annual reassessment EMEA/H/C/264/S/3 (2002)1955 of 17/05/2002
06/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/I/4
15/07/2002 Centralised - Variation EMEA/H/C/264/I/5 (2002)2707 of 10/07/2002
29/10/2002 Centralised - Variation EMEA/H/C/264/II/10 (2002)4303 of 24/10/2002
26/03/2003 Centralised - Annual reassessment EMEA/H/C/264/S/11 (2003)1039 of 24/03/2003
22/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/I/6
15/07/2003 Centralised - Variation EMEA/H/C/264/II/12 (2003)2538 of 09/07/2003
30/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/I/14
26/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/II/13
03/02/2004 Centralised - Variation EMEA/H/C/264/II/16, 17 (2004)289 of 29/01/2004
16/02/2004 Centralised - Variation EMEA/H/C/264/IB/20
Updated with Decision(2004)4297 of 28/10/2004
12/03/2004 Centralised - Annual reassessment EMEA/H/C/264/S/19 (2004)861 of 10/03/2004
24/05/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/IA/21
30/06/2004 Centralised - Notification EMEA/H/C/264/N/22
Updated with Decision(2004)4297 of 28/10/2004
01/11/2004 Centralised - Variation (2004)4297 of 28/10/2004
22/12/2004 Centralised - Variation EMEA/H/C/264/II/23 (2004)5395 of 17/12/2004
26/08/2005 Centralised - Variation EMEA/H/C/264/II/25 (2005)3271 of 24/08/2005
21/11/2005 Centralised - Renewal EMEA/H/C/264/R/24 (2005)4541 of 17/11/2005
05/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/IA/27
04/05/2006 Centralised - Variation EMEA/H/C/264/II/26 (2006)1883 of 02/05/2006
15/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/IA/31
10/01/2007 Centralised - Variation EMEA/H/C/264/II/29 (2007)69 of 08/01/2007
26/01/2007 Centralised - Variation EMEA/H/C/264/II/30 (2007)259 of 24/01/2007
02/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/264/IB/32
02/03/2007 Centralised - Variation EMEA/H/C/264/II/28 (2007)747 of 28/02/2007
30/07/2007 Centralised - Variation EMEA/H/C/264/II/34 (2007)3705 of 25/07/2007
05/09/2007 Centralised - Variation EMEA/H/C/264/II/33 (2007)4162 of 30/08/2007
16/11/2007 Centralised - Variation EMEA/H/C/264/IA/37
Updated with Decision(2008)418 of 28/01/2008
16/11/2007 Centralised - Variation EMEA/H/C/264/IA/38
Updated with Decision(2008)418 of 28/01/2008
04/12/2007 Centralised - Variation EMEA/H/C/264/II/35 (2007)6091 of 30/11/2007
30/01/2008 Centralised - Variation EMEA/H/C/264/II/36 (2008)418 of 28/01/2008
20/06/2008 Centralised - Variation EMEA/H/C/264/II/39 (2008)3074 of 18/06/2008
30/10/2008 Centralised - Variation EMEA/H/C/264/II/40 (2008)6484 of 28/10/2008
24/02/2009 Centralised - Variation EMEA/H/C/264/IA/41
Updated with Decision(2009)7835 of 07/10/2009
09/10/2009 Centralised - Variation (2009)7835 of 07/10/2009
24/11/2009 Centralised - Variation EMEA/H/C/264/II/42 (2009)9345 of 20/11/2009
23/12/2009 Centralised - Variation EMEA/H/C/264/II/44 (2009)10707 of 21/12/2009
05/05/2010 Centralised - Withdrawal (2010)2927 of 29/04/2010