Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tygacil   
Auth. number : EU/1/06/336
Active substance : Tigecycline
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01A - Tetracyclines
Chemical subgroup: J01AA - Tetracyclines
Chemical substance: J01AA12 - Tigecycline
(See WHO ATC Index)
Indication: Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):

• Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4);
• Complicated intra-abdominal infections (cIAI).

Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
26/04/2006 Centralised - Authorisation EMEA/H/C/644 (2006)1759 of 24/04/2006
11/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/3
11/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/2
29/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/4
15/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/5
14/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/7
16/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/11
20/03/2007 Centralised - Notification EMEA/H/C/644/N/9
Updated with Decision(2007)3284 of 29/06/2007
14/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/10
05/07/2007 Centralised - Variation EMEA/H/C/644/II/6 (2007)3284 of 29/06/2007
24/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/II/8
11/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/17
20/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/16
26/10/2007 Centralised - Variation EMEA/H/C/644/II/15 (2007)5299 of 24/10/2007
29/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/19
04/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/20
21/12/2007 Centralised - Variation EMEA/H/C/644/II/12 (2007)6768 of 19/12/2007
31/03/2008 Centralised - Variation EMEA/H/C/644/II/14 (2008)1249 of 27/03/2008
15/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/21
19/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/23
20/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/22
27/06/2008 Centralised - Variation (rejected) EMEA/H/C/644/II/18 (2008)3292 of 25/06/2008
04/11/2008 Centralised - Variation EMEA/H/C/644/II/24 (2008)6605 of 30/10/2008
06/02/2009 Centralised - Notification EMEA/H/C/644/N/27
Updated with Decision(2009)5602 of 07/07/2009
09/07/2009 Centralised - Variation EMEA/H/C/644/II/28 (2009)5602 of 07/07/2009
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/II/32
29/03/2010 Centralised - Variation EMEA/H/C/644/II/35 (2010)2179 of 26/03/2010
03/05/2010 Centralised - Variation EMEA/H/C/644/II/34 (2010)2948 of 29/04/2010
06/05/2010 Centralised - Variation EMEA/H/C/644/IA/36
Updated with Decision(2010)4680 of 01/07/2010
06/05/2010 Centralised - Variation EMEA/H/C/644/IA/37
Updated with Decision(2010)4680 of 01/07/2010
06/05/2010 Centralised - Variation EMEA/H/C/644/IA/38
Updated with Decision(2010)4680 of 01/07/2010
06/05/2010 Centralised - Variation EMEA/H/C/644/IA/39
Updated with Decision(2010)4680 of 01/07/2010
06/05/2010 Centralised - Variation EMEA/H/C/644/IA/40
Updated with Decision(2010)4680 of 01/07/2010
10/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/44
10/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/45
11/05/2010 Centralised - Variation EMEA/H/C/644/IB/46
Updated with Decision(2010)4680 of 01/07/2010
19/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/47
22/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/43
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/43
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/42
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/41
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IA/49
06/07/2010 Centralised - Variation EMEA/H/C/644/II/33 (2010)4680 of 01/07/2010
05/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/50
16/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/48
21/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/644/IB/52/G
12/05/2011 Centralised - Variation - Decision addressed to Member States EMEA/H/C/644/R/53 (2011)3235 of 06/05/2011
12/05/2011 Centralised - Renewal EMEA/H/C/644/R/53 (2011)3234 of 06/05/2011
26/05/2011 Centralised - Variation EMEA/H/C/644/WS/117 (2011)3730 of 23/05/2011
23/06/2011 Centralised - Variation EMEA/H/C/644/II/55 (2011)4468 of 17/06/2011
30/08/2011 Centralised - Variation EMEA/H/C/644/II/57 (2011)6149 of 24/08/2011
28/09/2011 Centralised - Variation EMEA/H/C/644/IA/62/G
Updated with Decision(2011)7931 of 27/10/2011
04/11/2011 Centralised - Variation EMEA/H/C/644/II/58 (2011)7931 of 27/10/2011
23/11/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/644/T/63 (2011)8652 of 21/11/2011
03/09/2012 Centralised - Variation EMEA/H/C/644/II/69 (2012)6120 of 30/08/2012
12/11/2012 Centralised - Variation EMEA/H/C/644/IAin/73/G
Updated with Decision(2013)8148 of 15/11/2013
04/12/2012 Referral EMEA/H/C/644/A-20/72 (2012)9090 of 30/11/2012
17/01/2013 Centralised - Variation EMEA/H/C/644/II/74
Updated with Decision(2013)8148 of 15/11/2013
12/07/2013 Centralised - Notification EMEA/H/C/644/N/78
Updated with Decision(2013)8148 of 15/11/2013
27/08/2013 Centralised - Variation EMEA/H/C/644/IB/79
Updated with Decision(2013)8148 of 15/11/2013
19/11/2013 Centralised - Yearly update EMEA/H/C/644/YU (2013)8148 of 15/11/2013
21/11/2013 Centralised - Variation EMEA/H/C/644/II/80
Updated with Decision(2014)8724 of 17/11/2014
21/11/2013 Centralised - Variation EMEA/H/C/644/II/81/G
Updated with Decision(2014)8724 of 17/11/2014
19/08/2014 Centralised - Notification EMEA/H/C/644/N/87
Updated with Decision(2014)8724 of 17/11/2014
19/11/2014 Centralised - Yearly update (2014)8724 of 17/11/2014
18/12/2014 Centralised - Variation EMEA/H/C/644/II/89
Updated with Decision(2015)3728 of 28/05/2015
01/06/2015 Centralised - 2-Monthly update EMEA/H/C/644/II/92 (2015)3728 of 28/05/2015
24/06/2015 Centralised - Notification EMEA/H/C/644/N/93
Updated with Decision(2016)1210 of 22/02/2016
25/06/2015 Centralised - Variation EMEA/H/C/644/II/94
Updated with Decision(2016)1210 of 22/02/2016
24/02/2016 Centralised - Renewal EMEA/H/C/644/R/95 (2016)1210 of 22/02/2016
11/05/2016 Centralised - Variation EMEA/H/C/644/IAin/98
17/06/2016 Centralised - Notification EMEA/H/C/644/N/99
28/07/2016 Centralised - Variation EMEA/H/C/644/IAin/100