Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: PREZISTA   
Auth. number : EU/1/06/380
INN : darunavir
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: J05AE10 - Darunavir
(See WHO ATC Index)
Indication: PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2).
PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult patients (see section 4.2).
In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
14/02/2007 Centralised - Authorisation EMEA/H/C/707 (2007)508 of 12/02/2007
12/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/707/IA/1
23/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/707/II/3
26/07/2007 Centralised - Variation EMEA/H/C/707/II/2 (2007)3652 of 24/07/2007
29/08/2007 Centralised - Variation EMEA/H/C/707/II/4, 5, 6 (2007)4074 of 27/08/2007
20/12/2007 Centralised - Variation EMEA/H/C/707/II/7, 9 (2007)6754 of 18/12/2007
14/01/2008 Centralised - Annual renewal EMEA/H/C/707/R/8 (2008)63 of 10/01/2008
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/707/II/13
24/06/2008 Centralised - Variation EMEA/H/C/707/II/11 (2008)3193 of 20/06/2008
08/07/2008 Centralised - Variation EMEA/H/C/707/II/17 (2008)3534 of 04/07/2008
30/07/2008 Centralised - Variation EMEA/H/C/707/I/12 (2008)4107 of 28/07/2008
02/09/2008 Centralised - Variation EMEA/H/C/707/II/18 (2008)4772 of 29/08/2008
28/10/2008 Centralised - Variation EMEA/H/C/707/II/23 (2008)6366 of 24/10/2008
27/11/2008 Centralised - Variation EMEA/H/C/707/II/14 (2008)7608 of 25/11/2008
18/12/2008 Centralised - Authorisation (orphan status) EMEA/H/C/707/R/22 (2008)8733 of 16/12/2008
24/12/2008 Centralised - Variation EMEA/H/C/707/II/10, 15 (2008)8975 of 22/12/2008
02/02/2009 Centralised - Variation EMEA/H/C/707/X/16, 19 (2009)667 of 29/01/2009
25/06/2009 Centralised - Variation EMEA/H/C/707/X/20&21 (2009)5144 of 23/06/2009
25/06/2009 Centralised - Variation EMEA/H/C/707/II/25 (2009)5145 of 23/06/2009
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/707/II/28
27/10/2009 Centralised - Variation EMEA/H/C/707/II/24, 26, 27 (2009)8403 of 23/10/2009
17/03/2010 Centralised - Variation EMEA/H/C/707/II/30 (2010)1819 of 15/03/2010
31/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/707/IB/33/G
04/06/2010 Centralised - Variation EMEA/H/C/707/II/29 (2010)3640 of 02/06/2010
23/07/2010 Centralised - Variation EMEA/H/C/707/IB/36
Updated with Decision(2010)8658 of 29/11/2010
23/07/2010 Centralised - Variation EMEA/H/C/707/IA/34
Updated with Decision(2010)8658 of 29/11/2010
23/07/2010 Centralised - Variation EMEA/H/C/707/IB/35/G
Updated with Decision(2010)8658 of 29/11/2010
22/09/2010 Centralised - Variation EMEA/H/C/707/IG/23/G
Updated with Decision(2010)8658 of 29/11/2010
02/12/2010 Centralised - Variation EMEA/H/C/707/II/37 (2010)8658 of 29/11/2010
04/03/2011 Centralised - Variation EMEA/H/C/707/II/32 (2011)1504 of 28/02/2011
22/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/707/IB/40
23/05/2011 Centralised - Variation EMEA/H/C/707/II/38 (2011)3613 of 18/05/2011
02/08/2011 Centralised - Variation EMEA/H/C/707/II/39 (2011)5608 of 27/07/2011
23/02/2012 Centralised - Variation EMEA/H/C/707/II/44/G (2012)1260 of 21/02/2012
12/04/2012 Centralised - Variation EMEA/H/C/707/IB/48
Updated with Decision(2012)4500 of 27/06/2012
02/07/2012 Centralised - Variation EMEA/H/C/707/II/47 (2012)4500 of 27/06/2012
30/08/2012 Centralised - Variation EMEA/H/C/707/IB/50
Updated with Decision(2013)138 of 14/01/2013
26/10/2012 Centralised - Variation EMEA/H/C/707/X/41/G, EMEA/H/C/707/II/49 (2012)7654 of 24/10/2012
16/11/2012 Centralised - Variation EMEA/H/C/707/II/52
Updated with Decision(2013)4234 of 01/07/2013
17/01/2013 Centralised - Variation EMEA/H/C/707/IB/50, EMEA/H/C/707/X/46 (2013)138 of 14/01/2013
15/05/2013 Centralised - Variation EMEA/H/C/707/IB/56
Updated with Decision(2013)4234 of 01/07/2013
03/07/2013 Centralised - 2-Monthly update EMEA/H/C/707/WS/396 (2013)4234 of 01/07/2013
23/09/2013 Centralised - Modification EMEA/H/C/707/II/54, EMEA/H/C/707/PSUV/59 (2013)6228 of 19/09/2013
23/09/2013 Centralised - Renewal EMEA/H/C/707/R/55 (2013)6227 of 19/09/2013
19/11/2013 Centralised - 2-Monthly update EMEA/H/C/707/IB/61 (2013)8158 of 15/11/2013
20/03/2014 Centralised - Variation EMEA/H/C/707/WS/507
Updated with Decision(2014)8294 of 30/10/2014
25/09/2014 Centralised - Variation EMEA/H/C/707/II/67/G
Updated with Decision(2014)8294 of 30/10/2014
03/11/2014 Centralised - 2-Monthly update EMEA/H/C/707/II/63, 64 (2014)8294 of 30/10/2014