This is a summary of the European public assessment report (EPAR) for Cubicin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cubicin.
For practical information about using Cubicin, patients should read the package leaflet or contact their doctor or pharmacist.
Cubicin : EPAR - Summary for the public (PDF/89.51 KB)
First published: 09/09/2009
Last updated: 04/01/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp & Dohme B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
07/08/2018 Cubicin - EMEA/H/C/000637 - T/0069
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antibacterials for systemic use
Cubicin is indicated for the treatment of the following infections.
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
- Adult patients with 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.
- Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated 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.