Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ketek   
Auth. number : EU/1/01/191
INN : 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: When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance.

Ketek is indicated for the treatment of the following infections:

In patients of 18 years and older:
  • Community-acquired pneumonia, mild or moderate.
  • When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin:
    • Acute exacerbation of chronic bronchitis,
    • Acute sinusitis

In patients of 12 years and older:
  • Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA.
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/354 (2001)1400 of 09/07/2001
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/I/1, 2
26/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/II/3
10/04/2002 Centralised - Notification EMEA/H/C/354/N/5 (2002)1323 of 26/03/2002
12/06/2002 Centralised - Variation EMEA/H/C/354/II/4 (2002)2172 of 07/06/2002
24/06/2002 Centralised - Notification EMEA/H/C/354/N/9 (2002)2421 of 20/06/2002
28/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/I/6, 8
24/07/2002 Centralised - Variation EMEA/H/C/354/I/7 (2002)2881 of 22/07/2002
06/03/2003 Centralised - Variation EMEA/H/C/354/II/10, 11 (2003)751 of 04/03/2003
09/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/I/13
15/07/2003 Centralised - Variation EMEA/H/C/354/II/12 (2003)2553 of 09/07/2003
20/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/I/17
10/10/2003 Centralised - Variation EMEA/H/C/354/II/14, 16 (2003)3722 of 08/10/2003
24/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/II/18
29/01/2004 Centralised - Variation EMEA/H/C/354/II/15 (2004)243 of 27/01/2004
26/02/2004 Centralised - Variation EMEA/H/C/354/IA/19
Updated with Decision(2004)4123 of 15/10/2004
01/07/2004 Centralised - Notification EMEA/H/C/354/N/20
Updated with Decision(2004)4123 of 15/10/2004
05/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IB/21
19/10/2004 Centralised - Variation (2004)4123 of 15/10/2004
01/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IB/23
12/01/2005 Centralised - Variation EMEA/H/C/354/II/22 (2005)61 of 10/01/2005
18/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/27
18/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/26
09/03/2005 Centralised - Variation EMEA/H/C/354/II/24 (2005)663 of 07/03/2005
12/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IB/28
19/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IB/29
19/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IB/30
07/06/2005 Centralised - Variation EMEA/H/C/354/II/25 (2005)1736 of 03/06/2005
09/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/31
04/08/2005 Centralised - Notification EMEA/H/C/354/N/32
Updated with Decision(2006)1039 of 22/03/2006
26/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IB/33
24/03/2006 Centralised - Variation EMEA/H/C/354/II/36 (2006)1039 of 22/03/2006
02/05/2006 Centralised - Variation EMEA/H/C/354/II/35 (2006)1822 of 27/04/2006
09/08/2006 Centralised - Variation EMEA/H/C/354/II/38, 39 (2006)3661 of 07/08/2006
12/09/2006 Centralised - Renewal EMEA/H/C/354/R/34 (2006)4129 of 07/09/2006
30/10/2006 Centralised - Variation EMEA/H/C/354/II/37 (2006)5200 of 26/10/2006
09/01/2007 Centralised - Variation EMEA/H/C/354/II/40 (2007)34 of 04/01/2007
04/06/2007 Other procedure EMEA/H/C/354/A-22/41 (2007)2376 of 31/05/2007
28/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/43
28/02/2008 Centralised - Variation EMEA/H/C/354/IA/42
28/02/2008 Centralised - Variation EMEA/H/C/354/IA/42
Updated with Decision(2008)6483 of 28/10/2008
06/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/44
06/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/45
08/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/354/IA/46
30/10/2008 Centralised - Variation EMEA/H/C/354/II/47 (2008)6483 of 28/10/2008
05/06/2009 Centralised - Variation EMEA/H/C/354/II/48 (2009)4401 of 02/06/2009
06/11/2009 Centralised - Variation EMEA/H/C/354/II/49 (2009)8660 of 04/11/2009
13/04/2010 Centralised - Variation EMEA/H/C/354/II/50 (2010)2412 of 09/04/2010
16/05/2011 Centralised - Renewal EMEA/H/C/354/R/51 (2011)3437 of 12/05/2011
08/12/2011 Centralised - Variation EMEA/H/C/354/IB/52/G
Updated with Decision(2012)4356 of 21/06/2012
25/06/2012 Centralised - Variation (2012)4356 of 21/06/2012
25/07/2012 Centralised - Variation EMEA/H/C/354/II/55 (2012)5348 of 23/07/2012
22/11/2012 Centralised - Variation EMEA/H/C/354/II/57 (2012)8594 of 19/11/2012
26/07/2013 Centralised - Variation EMEA/H/C/354/IA/59/G
Updated with Decision(2014)2835 of 23/04/2014
04/12/2013 Centralised - Variation EMEA/H/C/354/IA/61
Updated with Decision(2014)2835 of 23/04/2014
25/04/2014 Centralised - Modification EMEA/H/C/354/PSUV/60 (2014)2835 of 23/04/2014
24/07/2014 Centralised - Variation EMEA/H/C/354/II/62