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Pharmaceuticals - Community Register
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
Invented name: | Levviax |
Auth. number : | EU/1/01/192 |
Active substance : | telithromycin |
ATC: | Anatomical main group: J - General antiinfectives for systemic use Therapeutic subgroup: J01 - Antibacterials for systemic use Pharmacological subgroup: J01F - Macrolides and lincosamides Chemical subgroup: J01FA - Macrolides Chemical substance: J01FA15 - telithromycin (See WHO ATC Index) |
Indication: | Antibiotic |
Marketing Authorisation Holder: | Aventis Pharma S.A.
20 avenue Raymond Aron, 92165 Antony CEDEX, France |
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 procedures |
Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
10/07/2001 | Centralised - Authorisation | EMEA/H/C/355 | (2001)1399 of 09/07/2001 | |||
07/11/2001 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/I/1, 2 | ||||
26/02/2002 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/II/3 | ||||
04/04/2002 | Centralised - Notification | EMEA/H/C/355/N/5 | (2002)1367 of 27/03/2002 | |||
12/06/2002 | Centralised - Variation | EMEA/H/C/335/II/4 | (2002)2173 of 07/06/2002 | |||
24/06/2002 | Centralised - Notification | EMEA/H/C/355/N/9 | (2002)2422 of 20/06/2002 | |||
28/06/2002 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/I/6, 8 | ||||
24/07/2002 | Centralised - Variation | EMEA/H/C/355/I/4 | (2002)2882 of 22/07/2002 | |||
05/03/2003 | Centralised - Variation | EMEA/H/C/355/II/10, 11 | (2003)746 of 03/03/2003 | |||
09/04/2003 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/I/13 | ||||
15/07/2003 | Centralised - Variation | EMEA/H/C/355/II/12 | (2003)2551 of 09/07/2003 | |||
20/08/2003 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/I/17 | ||||
10/10/2003 | Centralised - Variation | EMEA/H/C/355/II/14, 16 | (2003)3721 of 08/10/2003 | |||
24/11/2003 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/II/18 | ||||
29/01/2004 | Centralised - Variation | EMEA/H/C/355/II/15 | (2004)244 of 27/01/2004 | |||
26/02/2004 | Centralised - Variation | EMEA/H/C/355/IA/19 | ||||
Updated with Decision(2004)4122 of 13/10/2004 | ||||||
01/07/2004 | Centralised - Notification | EMEA/H/C/355/N/20 | ||||
Updated with Decision(2004)4122 of 13/10/2004 | ||||||
05/07/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IB/21 | ||||
19/10/2004 | Centralised - Variation | (2004)4122 of 13/10/2004 | ||||
01/12/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IB/23 | ||||
12/01/2005 | Centralised - Variation | EMEA/H/C/355/II/22 | (2005)62 of 10/01/2005 | |||
18/01/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IA/27 | ||||
18/01/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IA/26 | ||||
09/03/2005 | Centralised - Variation | EMEA/H/C/355/II/24 | (2005)664 of 07/03/2005 | |||
12/04/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IB/28 | ||||
19/05/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IB/30 | ||||
19/05/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IB/29 | ||||
07/06/2005 | Centralised - Variation | EMEA/H/C/355/II/25 | (2005)1737 of 03/06/2005 | |||
09/06/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IA/31 | ||||
04/08/2005 | Centralised - Notification | EMEA/H/C/355/N/32 | ||||
Updated with Decision(2006)1038 of 22/03/2006 | ||||||
26/01/2006 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/355/IB/33 | ||||
24/03/2006 | Centralised - Variation | EMEA/H/C/355/II/36 | (2006)1038 of 22/03/2006 | |||
02/05/2006 | Centralised - Variation | EMEA/H/C/355/II/35 | (2006)1820 of 27/04/2006 | |||
09/08/2006 | Centralised - Variation | EMEA/H/C/355/II/38, 39 | (2006)3660 of 07/08/2006 | |||
12/09/2006 | Centralised - Renewal | EMEA/H/C/355/R/34 | (2006)4128 of 07/09/2006 | |||
30/10/2006 | Centralised - Variation | EMEA/H/C/355/II/37 | (2006)5202 of 26/10/2006 | |||
09/01/2007 | Centralised - Variation | EMEA/H/C/355/II/40 | (2007)35 of 04/01/2007 | |||
05/06/2007 | Referral | EMEA/H/C/354/A-22/41 | (2007)2377 of 31/05/2007 | |||
20/12/2007 | Centralised - Withdrawal | (2007)6727 of 18/12/2007 |