Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use
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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, F-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 proceduresGoto top of the page
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