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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Zerit
|
| Auth. number : | EU/1/96/009 |
| INN : | Stavudine |
| ATC: | J - General antiinfectives for systemic use J05 - Antivirals for systemic use J05A - Agents affecting the virus directly J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| 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/39 | (2005)155 of 20/01/2005 | |||
| 24/01/2005 | Centralised - Variation | EMEA/H/C/110/II/40 | (2005)158 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 | Other procedure | - | ||||
| 10/08/2005 | Centralised - Variation | EMEA/H/C/110/IA/45 | ||||
| Updated with Decision(2006)1614 of 10/04/2006 | ||||||
| 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/47 | ||||
| 01/02/2006 | Centralised - Variation | EMEA/H/C/110/IB/48 | ||||
| 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/69 | ||||
| 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 | ||||
| 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 | - |