Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Stocrin   
Auth. number : EU/1/99/111
Active substance : efavirenz
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: J05AG - Non-nucleoside reverse transcriptase inhibitors
Chemical substance: J05AG03 - nevirapine
(See WHO ATC Index)
Indication: STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.

STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
7/06/1999 Centralised - Authorisation EMEA/H/C/250 (1999)1429 of 28/05/1999
17/08/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/3
15/09/1999 Centralised - Variation EMEA/H/C/250/I/1 (1999)2819 of 25/08/1999
2/02/2000 Centralised - Variation EMEA/H/C/250/II/2 (2000)124 of 31/01/2000
31/05/2000 Centralised - Variation EMEA/H/C/250/II/4 (2000)1285 of 24/05/2000
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/II/9
19/10/2000 Centralised - Variation EMEA/H/C/250/II/6, 8 (2000)2826 of 13/10/2000
14/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/II/11
14/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/16
19/06/2001 Centralised - Variation EMEA/H/C/250/II/12 (2001)1324 of 14/06/2001
24/09/2001 Centralised - Variation EMEA/H/C/250/II/14 (2001)2735 of 20/09/2001
25/10/2001 Centralised - Variation EMEA/H/C/250/X/7 (2001)2972 of 24/10/2001
7/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/20
7/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/21
8/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/23
8/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/22
16/04/2002 Centralised - Variation EMEA/H/C/250/II/19 (2002)1469 of 12/04/2002
27/08/2002 Centralised - Variation EMEA/H/C/250/X/17, 18 (2002)3181 of 22/08/2002
5/09/2002 Centralised - Variation EMEA/H/C/250/II/25 (2002)3321 of 30/08/2002
4/10/2002 Centralised - Variation EMEA/H/C/250/II/24 (2002)3647 of 30/09/2002
27/05/2003 Centralised - Variation EMEA/H/C/250/II/26 (2003)1801 of 23/05/2003
27/06/2003 Centralised - Variation EMEA/H/C/250/I/28 (2003)2089 of 25/06/2003
15/07/2003 Centralised - Variation EMEA/H/C/250/II/27 (2003)2563 of 9/07/2003
22/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/29
23/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/I/31
10/02/2004 Centralised - Variation EMEA/H/C/250/II/30 (2004)428 of 6/02/2004
7/05/2004 Centralised - Renewal EMEA/H/C/250/R/33 (2004)1776 of 29/04/2004
15/07/2004 Centralised - Variation EMEA/H/C/250/II/32 (2004)2807 of 13/07/2004
14/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/36
11/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/35
8/12/2004 Centralised - Variation EMEA/H/C/250/II/34 (2004)4848 of 6/12/2004
20/12/2004 Centralised - Variation EMEA/H/C/250/IA/43
Updated with Decision(2005)665 of 07/03/2005
20/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/42
7/01/2005 Centralised - Variation EMEA/H/C/250/II/37 (2005)20 of 5/01/2005
17/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/39
17/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/40
17/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/41
17/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/44
9/03/2005 Centralised - Variation EMEA/H/C/250/II/38 (2005)665 of 7/03/2005
11/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/45
3/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/48
9/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/50
28/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/56
28/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/55
10/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/49
11/08/2005 Centralised - Variation EMEA/H/C/250/II/46, 47 (2005)3162 of 9/08/2005
27/10/2005 Centralised - Variation EMEA/H/C/250/II/52, 53, 54 (2005)4266 of 25/10/2005
3/01/2006 Centralised - Variation EMEA/H/C/250/II/51 (2005)6010 of 23/12/2005
14/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/59
6/09/2006 Centralised - Variation EMEA/H/C/250/II/60 (2006)4062 of 1/09/2006
30/10/2006 Centralised - Variation EMEA/H/C/250/II/61 (2006)5209 of 26/10/2006
28/11/2006 Centralised - Variation EMEA/H/C/250/X/57, 58 (2006)5861 of 24/11/2006
19/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/63
18/01/2007 Centralised - Variation EMEA/H/C/250/II/62 (2007)166 of 15/01/2007
4/05/2007 Centralised - Variation EMEA/H/C/250/II/64 (2007)2027 of 2/05/2007
5/07/2007 Centralised - Variation EMEA/H/C/250/II/65 (2007)3307 of 2/07/2007
27/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/68
28/08/2007 Centralised - Variation EMEA/H/C/250/II/67 (2007)4049 of 23/08/2007
10/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/69
9/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/II/66
15/07/2008 Centralised - Variation EMEA/H/C/250/II/72 (2008)3703 of 11/07/2008
2/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/74
2/12/2008 Centralised - Variation EMEA/H/C/250/II/73 (2008)7854 of 28/11/2008
16/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/77
24/04/2009 Centralised - Renewal EMEA/H/C/250/R/76 (2009)3185 of 22/04/2009
5/06/2009 Centralised - Variation EMEA/H/C/250/II/75 (2009)4422 of 2/06/2009
21/07/2009 Centralised - Variation EMEA/H/C/250/II/78 (2009)5870 of 17/07/2009
11/12/2009 Centralised - Variation EMEA/H/C/250/II/79 (2009)10141 of 9/12/2009
9/11/2010 Centralised - Variation EMEA/H/C/250/II/80 (2010)7733 of 3/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/250/IG/27/G
Updated with Decision(2011)1208 of 21/02/2011
8/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IA/82
1/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/250/IB/81/G
25/02/2011 Centralised - Variation (2011)1208 of 21/02/2011
22/03/2011 Centralised - Variation EMEA/H/C/250/IB/83
Updated with Decision(2011)5203 of 13/07/2011
31/05/2011 Centralised - Variation EMEA/H/C/250/IA/84
Updated with Decision(2011)5203 of 13/07/2011
18/07/2011 Centralised - Variation EMEA/H/C/250/WS/116 (2011)5203 of 13/07/2011
2/07/2012 Centralised - Variation EMEA/H/C/250/WS/210 (2012)4506 of 27/06/2012
1/05/2013 Centralised - 2-Monthly update EMEA/H/C/250/WS/357 (2013)2643 of 29/04/2013
3/07/2013 Centralised - 2-Monthly update EMEA/H/C/250/WS/388 (2013)4240 of 1/07/2013
24/10/2013 Centralised - Variation EMEA/H/C/250/WS/433
Updated with Decision(2014)2812 of 23/04/2014
24/10/2013 Centralised - Variation EMEA/H/C/250/WS/435
Updated with Decision(2014)2812 of 23/04/2014
23/01/2014 Centralised - Variation EMEA/H/C/250/WS/486
Updated with Decision(2014)2812 of 23/04/2014
23/01/2014 Centralised - Variation EMEA/H/C/250/WS/434
Updated with Decision(2014)2812 of 23/04/2014
20/03/2014 Centralised - Variation EMEA/H/C/250/WS/475
Updated with Decision(2015)2126 of 23/03/2015
25/04/2014 Centralised - Renewal EMEA/H/C/250/R/96 (2014)2812 of 23/04/2014
20/11/2014 Centralised - Variation EMEA/H/C/250/WS/604
Updated with Decision(2015)2126 of 23/03/2015
25/03/2015 Centralised - Yearly update (2015)2126 of 23/03/2015
28/01/2016 Centralised - Variation EMEA/H/C/250/WS/893
Updated with Decision(2017) 1243 of 16/02/2017
20/02/2017 Centralised - Yearly update (2017) 1243 of 16/02/2017
19/12/2017 Centralised - 2-Monthly update EMEA/H/C/250/WS/1117/G (2017) 8916 of 15/12/2017
6/06/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/250/T/113 (2018)3689 of 4/06/2018
1/08/2018 Centralised - 2-Monthly update EMEA/H/C/250/II/114 (2018)5207 of 30/07/2018
24/10/2018 Centralised - Variation EMEA/H/C/250/IG/994
7/01/2019 Centralised - Variation EMEA/H/C/250/IB/118