Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: APTIVUS   
Auth. number : EU/1/05/315
INN : Tipranavir
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: J05AE09 - Tipranavir
(See WHO ATC Index)
Indication: APTIVUS, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. APTIVUS should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

  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
27/10/2005 Centralised - Authorisation EMEA/H/C/631 (2005)4254 of 25/10/2005
06/12/2005 Centralised - Variation EMEA/H/C/631/IA/2
28/12/2005 Centralised - Variation EMEA/H/C/631/II/1 (2005)6007 of 23/12/2005
10/01/2006 Centralised - Variation EMEA/H/C/631/IA/4
31/03/2006 Centralised - Variation EMEA/H/C/631/II/3 (2006)1344 of 29/03/2006
31/08/2006 Centralised - Variation EMEA/H/C/631/II/5, 6, 7 (2006)3920 of 28/08/2006
28/11/2006 Centralised - Variation EMEA/H/C/631/II/9, 11 (2006)5863 of 24/11/2006
26/01/2007 Centralised - Variation EMEA/H/C/631/II/13, 14 (2007)263 of 24/01/2007
01/03/2007 Centralised - Variation EMEA/H/C/631/II/10, 15, 16, 18 (2007)712 of 27/02/2007
23/03/2007 Centralised - Annual reassessment EMEA/H/C/631/S/12 (2007)1355 of 21/03/2007
17/04/2007 Centralised - Variation EMEA/H/C/631/IB/20
06/06/2007 Centralised - Variation EMEA/H/C/631/II/8 (2007)2447 of 04/06/2007
05/07/2007 Centralised - Variation EMEA/H/C/631/II/17, 21 (2007)3306 of 02/07/2007
18/10/2007 Centralised - Variation EMEA/H/C/631/II/24 (2007)5143 of 15/10/2007
24/10/2007 Centralised - Variation EMEA/H/C/631/II/22, 25 (2007)5247 of 22/10/2007
21/12/2007 Centralised - Variation EMEA/H/C/631/II/26 (2007)6776 of 19/12/2007
31/03/2008 Centralised - Variation EMEA/H/C/631/II/28 (2008)1250 of 27/03/2008
24/04/2008 Centralised - Annual reassessment EMEA/H/C/631/S/27 (2008)1686 of 22/04/2008
09/07/2008 Centralised - Variation EMEA/H/C/631/II/23 (2008)3561 of 07/07/2008
16/07/2008 Centralised - Variation EMEA/H/C/631/IA/31
23/10/2008 Centralised - Variation EMEA/H/C/631/II/34 (2008)6248 of 21/10/2008
29/12/2008 Centralised - Variation EMEA/H/C/631/II/33 (2008)8979 of 22/12/2008
04/03/2009 Centralised - Variation EMEA/H/C/631/II/32 (2009)1578 of 02/03/2009
03/06/2009 Centralised - Variation EMEA/H/C/631/II/35 (2009)4354 of 29/05/2009
25/06/2009 Centralised - Variation EMEA/H/C/631/X/30 (2009)5148 of 23/06/2009
25/06/2009 Centralised - Variation EMEA/H/C/631/II/29 (2009)5147 of 23/06/2009
16/09/2009 Centralised - Variation EMEA/H/C/631/N/38
Updated with Decision(2009)8134 of 16/10/2009
20/10/2009 Centralised - Variation EMEA/H/C/631/II/37 (2009)8134 of 16/10/2009
26/11/2009 Centralised - Variation EMEA/H/C/631/II/36 (2009)9446 of 23/11/2009
12/01/2010 Centralised - Variation EMEA/H/C/631/IA/39
12/01/2010 Centralised - Variation EMEA/H/C/631/IA/40
19/04/2010 Centralised - Variation EMEA/H/C/631/IA/42
19/04/2010 Centralised - Variation EMEA/H/C/631/IA/46/G
19/04/2010 Centralised - Variation EMEA/H/C/631/IA/44
19/04/2010 Centralised - Variation EMEA/H/C/631/IA/45/G
19/04/2010 Centralised - Variation EMEA/H/C/631/IA/43
26/05/2010 Centralised - Variation EMEA/H/C/631/IB/41/G
18/08/2010 Centralised - Variation EMEA/H/C/631/IA/48/G
07/10/2010 Centralised - Renewal EMEA/H/C/631/R/47 (2010)7029 of 05/10/2010
04/07/2011 Centralised - Variation EMEA/H/C/631/49/G, EMEA/H/C/631/II/50 (2011)4809 of 29/06/2011
21/12/2011 Centralised - Variation EMEA/H/C/631/II/52 (2011)9940 of 19/12/2011
25/07/2012 Centralised - Variation EMEA/H/C/631/N/56
Updated with Decision(2013)9757 of 18/12/2013
21/03/2013 Centralised - Variation EMEA/H/C/631/IB/58/G
Updated with Decision(2013)9757 of 18/12/2013
24/05/2013 Centralised - Variation EMEA/H/C/631/IB/59
Updated with Decision(2013)9757 of 18/12/2013
02/01/2014 Centralised - Variation EMEA/H/C/631/II/60 (2013)9757 of 18/12/2013
20/02/2014 Centralised - Variation EMEA/H/C/631/II/64