Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Invanz   
Auth. number : EU/1/02/216
INN : Ertapenem
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01D - Other beta-lactam antibacterials
Chemical subgroup: J01DH - Carbapenems
Chemical substance: J01DH03 - Ertapenem
(See WHO ATC Index)
Indication: Treatment

INVANZ is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteraltherapy is required (see sections 4.4 and 5.1):
- Intra-abdominal infections
- Community acquired pneumonia
- Acute gynaecological infections
- Diabetic foot infections of the skin and soft tissue (see section 4.4)

Prevention

INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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 continues to be 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
22/04/2002 Centralised - Authorisation EMEA/H/C/389 (2002)1545 of 18/04/2002
14/11/2002 Centralised - Variation EMEA/H/C/389/I/1 (2002)4503 of 12/11/2002
24/04/2003 Centralised - Variation EMEA/H/C/389/I/4 (2003)1402 of 22/04/2003
28/07/2003 Centralised - Variation EMEA/H/C/389/II/3
05/09/2003 Centralised - Variation EMEA/H/C/389/II/3
06/10/2003 Centralised - Variation EMEA/H/C/389/I/6
03/12/2003 Centralised - Variation EMEA/H/C/389/II/5 (2003)4601 of 01/12/2003
09/02/2004 Centralised - Variation EMEA/H/C/389/IB/8
Updated with Decision(2004)855 of 10/03/2004
12/03/2004 Centralised - Variation EMEA/H/C/389/II/7 (2004)855 of 10/03/2004
19/07/2004 Centralised - Variation EMEA/H/C/389/N/9
Updated with Decision(2005)2991 of 07/07/2005
20/12/2004 Centralised - Variation EMEA/H/C/389/II/10
22/02/2005 Centralised - Variation EMEA/H/C/389/IB/12
18/03/2005 Centralised - Variation EMEA/H/C/389/IB/14
11/07/2005 Centralised - Variation EMEA/H/C/389/II/11 (2005)2991 of 07/07/2005
27/01/2006 Centralised - Variation EMEA/H/C/389/II/13 (2006)224 of 25/01/2006
18/08/2006 Centralised - Variation EMEA/H/C/389/II/17
08/09/2006 Centralised - Variation EMEA/H/C/389/II/15 (2006)4071 of 01/09/2006
09/10/2006 Centralised - Variation EMEA/H/C/389/IB/18
26/10/2006 Centralised - Variation EMEA/H/C/389/II/16 (2006)5180 of 24/10/2006
26/01/2007 Centralised - Variation EMEA/H/C/389/N/20
Updated with Decision(2007)4077 of 27/08/2007
23/03/2007 Centralised - Renewal EMEA/H/C/389/R/19 (2007)1361 of 21/03/2007
18/04/2007 Centralised - Variation EMEA/H/C/389/IB/21
29/08/2007 Centralised - Variation EMEA/H/C/389/II/22 (2007)4077 of 27/08/2007
24/10/2007 Centralised - Variation EMEA/H/C/389/II/23
11/03/2008 Centralised - Variation EMEA/H/C/389/IA/25
01/10/2008 Centralised - Variation EMEA/H/C/389/IA/27
24/12/2008 Centralised - Variation EMEA/H/C/389/II/26 (2008)8976 of 22/12/2008
21/04/2009 Centralised - Variation EMEA/H/C/389/IB/28
28/07/2009 Centralised - Variation EMEA/H/C/389/II/29 (2009)5991 of 23/07/2009
01/09/2009 Centralised - Variation EMEA/H/C/389/II/30 (2009)6725 of 28/08/2009
27/10/2009 Centralised - Variation EMEA/H/C/389/II/31 (2009)8399 of 23/10/2009
02/08/2010 Centralised - Variation EMEA/H/C/389/II/32 (2010)5387 of 28/07/2010
07/10/2010 Centralised - Variation EMEA/H/C/389/IB/33
18/11/2010 Centralised - Variation EMEA/H/C/389/IG/27/G
Updated with Decision(2011)1482 of 28/02/2011
03/03/2011 Centralised - Variation (2011)1482 of 28/02/2011
03/01/2012 Centralised - Renewal EMEA/H/C/389/R/36 (2011)10099 of 22/12/2011
06/02/2012 Centralised - Variation EMEA/H/C/389/N/39
Updated with Decision(2012)4480 of 27/06/2012
29/06/2012 Centralised - Variation EMEA/H/C/389/II/40 (2012)4480 of 27/06/2012
12/07/2013 Centralised - Variation EMEA/H/C/389/N/47
21/11/2013 Centralised - Variation EMEA/H/C/389/II/48