Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zerit   
Auth. number : EU/1/96/009
INN : Stavudine
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: J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
Chemical substance: J05AF04 - Stavudine
(See WHO ATC Index)
Indication: Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected patients.
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
09/05/1996 Centralised - Authorisation EMEA/H/C/110 (96)2733 of 08/05/1996
16/10/1996 Centralised - Variation EMEA/H/C/110/I/3
20/01/1997 Centralised - Variation EMEA/H/C/110/I/1 (97)147 of 17/01/1997
04/02/1997 Centralised - Variation EMEA/H/C/110/II/4 (97)291 of 03/02/1997
29/07/1997 Centralised - Variation EMEA/H/C/110/II/5, 6, 7 (97)2568 of 28/07/1997
01/10/1997 Centralised - Variation EMEA/H/C/110/I/9
15/12/1997 Centralised - Variation EMEA/H/C/110/II/8 (97)4008 of 12/12/1997
06/04/1998 Centralised - Variation EMEA/H/C/110/N/10 (1998)855 of 03/04/1998
15/10/1998 Centralised - Variation EMEA/H/C/110/N/13 (1998)3100 of 09/10/1998
16/07/1999 Centralised - Variation EMEA/H/C/110/I/15
14/10/1999 Centralised - Variation EMEA/H/C/110/I/16
14/10/1999 Centralised - Variation EMEA/H/C/110/I/17
23/02/2000 Centralised - Variation EMEA/H/C/110/II/14 (2000)418 of 21/02/2000
31/05/2000 Centralised - Variation EMEA/H/C/110/N/18 (2000)1448 of 31/05/2000
25/07/2000 Centralised - Variation EMEA/H/C/110/N/19 (2000)2051 of 24/07/2000
23/01/2001 Centralised - Variation EMEA/H/C/110/N/20 (2001)48 of 22/01/2001
13/06/2001 Centralised - Renewal EMEA/H/C/110/R/24 (2001)1285 of 08/06/2001
21/06/2001 Centralised - Variation EMEA/H/C/110/II/23
09/07/2001 Centralised - Variation EMEA/H/C/110/II/21 (2001)1391 of 05/07/2001
23/11/2001 Centralised - Variation EMEA/H/C/110/I/27 (2001)3595 of 21/11/2001
04/02/2002 Centralised - Variation EMEA/H/C/110/I/29
07/02/2002 Centralised - Variation EMEA/H/C/110/II/26 (2002)418 of 30/01/2002
04/07/2002 Centralised - Variation EMEA/H/C/110/N/19 (2002)2560 of 28/06/2002
10/09/2002 Centralised - Variation EMEA/H/C/110/I/31
14/11/2002 Centralised - Variation EMEA/H/C/110/X/28 (2002)4501 of 12/11/2002
21/11/2002 Centralised - Variation EMEA/H/C/110/N/32 (2002)4582 of 20/11/2002
20/05/2003 Centralised - Variation EMEA/H/C/110/II/33 (2003)1704 of 16/05/2003
03/07/2003 Centralised - Variation EMEA/H/C/110/II/35 (2003)2237 of 30/06/2003
28/10/2003 Centralised - Variation EMEA/H/C/110/II/34 (2003)4012 of 24/10/2003
29/01/2004 Centralised - Variation EMEA/H/C/110/II/36 (2004)226 of 27/01/2004
30/04/2004 Centralised - Variation EMEA/H/C/110/II/37 (2004)1764 of 28/04/2004
29/11/2004 Centralised - Variation EMEA/H/C/110/IA/41
12/01/2005 Centralised - Variation EMEA/H/C/110/IA/42
24/01/2005 Centralised - Variation EMEA/H/C/110/II/40 (2005)158 of 20/01/2005
24/01/2005 Centralised - Variation EMEA/H/C/110/II/39 (2005)155 of 20/01/2005
17/03/2005 Centralised - Variation EMEA/H/C/110/IA/43
Updated with Decision(2005)3401 of 31/08/2005
28/06/2005 Centralised - Variation EMEA/H/C/110/N/38
Updated with Decision(2005)155 of 20/01/2005
10/08/2005 Centralised - Variation EMEA/H/C/110/IA/45
Updated with Decision(2006)1614 of 10/04/2006
10/08/2005 Other procedure
02/09/2005 Centralised - Variation EMEA/H/C/110/II/44 (2005)3401 of 31/08/2005
01/02/2006 Centralised - Variation EMEA/H/C/110/IB/48
01/02/2006 Centralised - Variation EMEA/H/C/110/IB/47
07/03/2006 Centralised - Variation EMEA/H/C/110/IB/49
13/04/2006 Centralised - Renewal EMEA/H/C/110/R/46 (2006)1614 of 10/04/2006
16/10/2006 Centralised - Variation EMEA/H/C/110/IB/51
16/10/2006 Centralised - Variation EMEA/H/C/110/IB/50
20/12/2006 Centralised - Variation EMEA/H/C/110/IA/53
23/01/2007 Centralised - Variation EMEA/H/C/110/II/52 (2007)202 of 19/01/2007
16/03/2007 Centralised - Variation EMEA/H/C/110/IA/54
25/04/2007 Centralised - Variation EMEA/H/C/110/IB/56
26/04/2007 Centralised - Variation EMEA/H/C/110/IB/56
20/11/2007 Centralised - Variation EMEA/H/C/110/IA/57
18/12/2007 Centralised - Variation EMEA/H/C/110/IA/60
05/02/2008 Centralised - Variation EMEA/H/C/110/IB/59
05/02/2008 Centralised - Variation EMEA/H/C/110/IB/58
21/07/2008 Centralised - Variation EMEA/H/C/110/N/61
Updated with Decision(2009)1384 of 25/02/2009
04/09/2008 Centralised - Variation EMEA/H/C/110/IB/64
04/09/2008 Centralised - Variation EMEA/H/C/110/IB/65
03/11/2008 Centralised - Variation EMEA/H/C/110/II/62
05/01/2009 Centralised - Variation EMEA/H/C/110/II/63
27/02/2009 Centralised - Variation EMEA/H/C/110/II/67 (2009)1384 of 25/02/2009
10/03/2009 Centralised - Variation EMEA/H/C/110/IA/68
Updated with Decision(2009)6724 of 28/08/2009
10/03/2009 Centralised - Variation EMEA/H/C/110/IA/70
10/03/2009 Centralised - Variation EMEA/H/C/110/IA/69
18/08/2009 Centralised - Variation EMEA/H/C/110/II/71
01/09/2009 Centralised - Variation EMEA/H/C/110/II/66 (2009)6724 of 28/08/2009
30/10/2009 Centralised - Variation EMEA/H/C/110/II/72 (2009)8515 of 28/10/2009
05/01/2010 Centralised - Variation EMEA/H/C/110/II/73
22/03/2010 Centralised - Variation EMEA/H/C/110/IA/74/G
Updated with Decision(2010)3703 of 04/06/2010
08/06/2010 Centralised - Variation (2010)3703 of 04/06/2010
12/08/2010 Centralised - Variation EMEA/H/C/110/IB/76
Updated with Decision(2010)8903 of 03/12/2010
09/09/2010 Centralised - Variation EMEA/H/C/110/II/75 (2010)6243 of 06/09/2010
09/09/2010 Centralised - Variation EMEA/H/C/110/IA/77/G
Updated with Decision(2010)8903 of 03/12/2010
29/09/2010 Centralised - Variation EMEA/H/C/110/IA/78
Updated with Decision(2010)8903 of 03/12/2010
07/12/2010 Centralised - Variation (2010)8903 of 03/12/2010
23/03/2011 Centralised - Variation EMEA/H/C/110/II/80 (2011)1927 of 18/03/2011
25/03/2011 Centralised - Variation EMEA/H/C/110/IA/81
27/04/2011 Centralised - Renewal EMEA/H/C/110/R/79 (2011)2942 of 20/04/2011
22/03/2012 Corrigendum
25/06/2013 Centralised - Variation EMEA/H/C/110/WS/388 (2013)4015 of 21/06/2013
20/03/2014 Centralised - Variation EMEA/H/C/110/WS/539
03/06/2014 Centralised - Variation EMEA/H/C/110/N/91
01/07/2014 Centralised - Variation EMEA/H/C/110/IA/92