Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Reyataz   
Auth. number : EU/1/03/267
INN : atazanavir sulphate
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: J05AE08 - Atazanavir
(See WHO ATC Index)
Indication: REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years . The choice of REYATAZ in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, 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
04/03/2004 Centralised - Authorisation EMEA/H/C/494 (2004)728 of 02/03/2004
21/07/2004 Centralised - Variation EMEA/H/C/494/II/1 (2004)2878 of 19/07/2004
22/12/2004 Centralised - Variation EMEA/H/C/494/II/4 (2004)5376 of 17/12/2004
04/03/2005 Centralised - Variation EMEA/H/C/494/II/5 (2005)455 of 21/02/2005
30/06/2005 Centralised - Variation EMEA/H/C/494/IA/8
30/06/2005 Centralised - Variation EMEA/H/C/494/IA/7
26/08/2005 Centralised - Variation EMEA/H/C/494/II/9 (2005)3275 of 24/08/2005
06/09/2005 Centralised - Variation EMEA/H/C/494/IB/12
09/09/2005 Centralised - Variation EMEA/H/C/494/IA/13
Updated with Decision(2005)4533 of 17/11/2005
20/09/2005 Centralised - Annual reassessment EMEA/H/C/494/S/6 (2005)3588 of 16/09/2005
21/11/2005 Centralised - Variation EMEA/H/C/494/II/10, 11 (2005)4533 of 17/11/2005
12/12/2005 Centralised - Variation EMEA/H/C/494/IA/16
09/01/2006 Centralised - Variation EMEA/H/C/494/IB/15
27/01/2006 Centralised - Variation EMEA/H/C/494/II/14 (2005)226 of 25/01/2006
10/02/2006 Centralised - Variation EMEA/H/C/494/IA/18
Updated with Decision(2006)3178 of 06/07/2006
20/02/2006 Centralised - Variation EMEA/H/C/494/IA/19
28/02/2006 Centralised - Variation EMEA/H/C/494/IA/20
Updated with Decision(2006)3178 of 06/07/2006
10/07/2006 Centralised - Variation EMEA/H/C/494/II/17 (2006)3178 of 06/07/2006
02/08/2006 Centralised - Annual reassessment EMEA/H/C/494/S/21 (2006)3556 of 28/07/2006
07/11/2006 Centralised - Variation EMEA/H/C/494/IA/24
18/12/2006 Centralised - Variation EMEA/H/C/494/IA/26
12/01/2007 Centralised - Variation EMEA/H/C/494/IB/23
19/01/2007 Centralised - Variation EMEA/H/C/494/II/25 (2007)179 of 17/01/2007
20/03/2007 Centralised - Variation EMEA/H/C/494/IA/28
29/03/2007 Centralised - Variation EMEA/H/C/494/II/22 (2007)1494 of 27/03/2007
30/04/2007 Centralised - Variation EMEA/H/C/494/II/27 (2007)1938 of 26/04/2007
05/06/2007 Centralised - Variation EMEA/H/C/494/IA/30
25/07/2007 Centralised - Annual reassessment EMEA/H/C/494/S/29 (2007)3637 of 20/07/2007
07/08/2007 Centralised - Variation EMEA/H/C/494/IA/35
17/12/2007 Centralised - Variation EMEA/H/C/494/IA/43
17/12/2007 Centralised - Variation EMEA/H/C/494/IA/42
17/12/2007 Centralised - Variation EMEA/H/C/494/IA/41
20/12/2007 Centralised - Variation EMEA/H/C/494/IB/40
21/12/2007 Centralised - Variation EMEA/H/C/494/II/32 (2007)6773 of 19/12/2007
08/01/2008 Centralised - Variation EMEA/H/C/494/IB/37
10/01/2008 Centralised - Variation EMEA/H/C/494/IA/45
15/01/2008 Centralised - Variation EMEA/H/C/494/IA/38
15/01/2008 Centralised - Variation EMEA/H/C/494/IB/36
26/02/2008 Centralised - Variation EMEA/H/C/494/II/44
21/04/2008 Centralised - Variation EMEA/H/C/494/X/33 (2008)1610 of 17/04/2008
24/04/2008 Centralised - Variation EMEA/H/C/494/II/46 (2008)1657 of 21/04/2008
24/06/2008 Centralised - Variation EMEA/H/C/494/II/31, 34, 39 (2008)3154 of 20/06/2008
29/07/2008 Centralised - Annual reassessment EMEA/H/C/494/S/47 (2008)4104 of 25/07/2008
29/07/2008 Centralised - Variation EMEA/H/C/494/IA/48
Updated with Decision(2008)6417 of 27/10/2008
27/08/2008 Centralised - Variation EMEA/H/C/494/IA/51
22/09/2008 Centralised - Variation EMEA/H/C/494/IA/53
29/10/2008 Centralised - Variation EMEA/H/C/494/II/50 (2008)6417 of 27/10/2008
06/02/2009 Centralised - Variation EMEA/H/C/494/IA/60
10/02/2009 Centralised - Renewal EMEA/H/C/494/R/52 (2009)969 of 06/02/2009
02/03/2009 Centralised - Variation EMEA/H/C/494/II/55 (2009)1467 of 26/02/2009
23/03/2009 Centralised - Variation EMEA/H/C/494/IA/62
Updated with Decision(2009)4051 of 15/05/2009
23/03/2009 Centralised - Variation EMEA/H/C/494/IA/61
20/05/2009 Centralised - Variation EMEA/H/C/494/II/63 (2009)4051 of 15/05/2009
05/06/2009 Centralised - Variation EMEA/H/C/494/IB/64
05/06/2009 Centralised - Variation EMEA/H/C/494/IB/66
05/06/2009 Centralised - Variation EMEA/H/C/4949/IB/65
10/06/2009 Centralised - Variation EMEA/H/C/494/II/54 (2009)4581 of 08/06/2009
09/07/2009 Centralised - Variation EMEA/H/C/494/II/49 (2009)5604 of 07/07/2009
24/11/2009 Centralised - Variation EMEA/H/C/494/II/59 (2009)9338 of 20/11/2009
25/11/2009 Centralised - Variation EMEA/H/C/494/II/67
17/03/2010 Centralised - Variation EMEA/H/C/494/II/56 (2010)1772 of 15/03/2010
06/04/2010 Centralised - Variation EMEA/H/C/494/IA/68/G
Updated with Decision(2010)4786 of 05/07/2010
08/07/2010 Centralised - Variation EMEA/H/C/494/II/57 (2010)4786 of 05/07/2010
19/08/2010 Centralised - Variation EMEA/H/C/494/IA/71
Updated with Decision(2011)2088 of 24/03/2011
30/09/2010 Centralised - Variation EMEA/H/C/494/IB/72
Updated with Decision(2011)2088 of 24/03/2011
04/10/2010 Centralised - Variation EMEA/H/C/494/IB/69/G
04/10/2010 Centralised - Variation EMEA/H/C/494/IA/73/G
28/03/2011 Centralised - Variation EMEA/H/C/494/IA/96
30/03/2011 Centralised - Variation EMEA/H/C/494/II/75 (2011)2088 of 24/03/2011
19/05/2011 Centralised - Variation EMEA/H/C/494/IB/77/G
Updated with Decision(2011)6146 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/494/II/74 (2011)6146 of 24/08/2011
24/11/2011 Centralised - Variation EMEA/H/C/494/II/70 (2011)8675 of 22/11/2011
19/04/2012 Centralised - Variation EMEA/H/C/494/IB/81
Updated with Decision(2012)4570 of 28/06/2012
03/07/2012 Centralised - Variation EMEA/H/C/494/II/80 (2012)4570 of 28/06/2012
28/08/2012 Centralised - Variation EMEA/H/C/494/II/82 (2012)6004 of 23/08/2012
21/03/2013 Centralised - Variation EMEA/H/C/494/II/84
Updated with Decision(2013)4018 of 21/06/2013
01/06/2013 Centralised - Variation EMEA/H/C/494/II/87
Updated with Decision(2013)8505 of 25/11/2013
25/06/2013 Centralised - Variation EMEA/H/C/494/WS/388 (2013)4018 of 21/06/2013
27/11/2013 Centralised - Variation EMEA/H/C/494/II/89 (2013)8505 of 25/11/2013
20/03/2014 Centralised - Variation EMEA/H/C/494/WS/539
25/04/2014 Centralised - Variation EMEA/H/C/494/II/90