Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cubicin   
Auth. number : EU/1/05/328
INN : Daptomycin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01X - Other antibacterials
Chemical subgroup: J01XX - Other antibacterials
Chemical substance: J01XX09 - Daptomycin
(See WHO ATC Index)
Indication: Cubicin is indicated for the treatment of the following infections in adults.
  • Complicated skin and soft-tissue infections (cSSTI).
  • Right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.
  • Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI.

Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
23/01/2006 Centralised - Authorisation EMEA/H/C/637 (2006)132 of 19/01/2006
09/02/2006 Corrigendum EMEA/H/C/637 (2006)132 corr of 07/02/2006
20/03/2006 Centralised - Variation EMEA/H/C/637/IA/1
Updated with Decision(2006)3435 of 25/07/2006
11/05/2006 Corrigendum EMEA/H/C/637 (2006)132 corr of 05/05/2006
28/07/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/637/T/4 (2006)3435 of 25/07/2006
23/10/2006 Centralised - Variation EMEA/H/C/637/II/3
07/05/2007 Centralised - Variation EMEA/H/C/637/IA/10
07/05/2007 Centralised - Variation EMEA/H/C/637/IA/7
06/06/2007 Centralised - Variation EMEA/H/C/637/IB/8, 9
31/07/2007 Centralised - Variation EMEA/H/C/637/N/6
Updated with Decision(2007)4183 of 31/08/2007
05/09/2007 Centralised - Variation EMEA/H/C/637/II/5 (2007)4183 of 31/08/2007
30/11/2007 Centralised - Variation EMEA/H/C/637/IA/12, 13, 14
21/12/2007 Centralised - Variation EMEA/H/C/637/II/11 (2007)6764 of 19/12/2007
18/01/2008 Centralised - Variation EMEA/H/C/637/IA/16
12/03/2008 Centralised - Variation EMEA/H/C/637/IA/17, 19, 20
29/04/2008 Centralised - Variation EMEA/H/C/637/II/15
24/07/2008 Centralised - Variation EMEA/H/C/637/II/21 (2008)3967 of 22/07/2008
04/02/2009 Centralised - Variation EMEA/H/C/637/IA/24
16/03/2009 Centralised - Variation EMEA/H/C/637/IB/25
21/04/2009 Centralised - Variation EMEA/H/C/637/X/22, 23 (2009)3066 of 17/04/2009
21/07/2009 Centralised - Variation EMEA/H/C/637/II/26 (2009)5837 of 16/07/2009
17/03/2010 Centralised - Variation EMEA/H/C/637/II/28 (2010)1780 of 15/03/2010
24/03/2010 Centralised - Variation EMEA/H/C/637/IA/30
30/03/2010 Centralised - Variation EMEA/H/C/637/II/29 (2010)2155 of 26/03/2010
09/04/2010 Centralised - Variation EMEA/H/C/637/IB/31
02/08/2010 Centralised - Variation EMEA/H/C/637/IB/33/G
Updated with Decision(2010)5995 of 26/08/2010
31/08/2010 Centralised - Variation EMEA/H/C/637/II/27, 32/G (2010)5995 of 26/08/2010
06/12/2010 Centralised - Renewal EMEA/H/C/637/R/34 (2010)8657 of 29/11/2010
13/01/2011 Centralised - Variation EMEA/H/C/637/IG/32/G
25/01/2011 Centralised - Variation EMEA/H/C/637/II/35 (2011)386 of 21/01/2011
24/02/2012 Centralised - Variation EMEA/H/C/637/II/39 (2012)1281 of 21/02/2012
07/12/2012 Centralised - Variation EMEA/H/C/637/IAin/43
Updated with Decision(2013)8836 of 03/12/2013
05/11/2013 Centralised - Variation EMEA/H/C/637/N/45
Updated with Decision(2013)8836 of 03/12/2013
06/12/2013 Centralised - Variation (2013)8836 of 03/12/2013
08/04/2014 Centralised - Variation EMEA/H/C/637/IB/48/G
23/04/2014 Centralised - Variation EMEA/H/C/637/IB/47