Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 23 August 2018

Indication(s)

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 coadministered with appropriate antibacterial agent(s).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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Category Value
Agency product number EMEA/H/C/000637
Orphan designation No
Date First Approved 19-01-2006
Type Medicinal product subject to medical prescription
Marketing authorisation holder Merck Sharp & Dohme Ltd