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Cubicin (daptomycin)

Region

🇪🇺 EU

Active substance

daptomycin

Status

Authorised

Therapeutic area

Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial

CHMP opinion

Thu 17 Nov 2005

EU approval

Thu 19 Jan 2006

Application

EMEA/H/C/000637

ATC

J01XX09

Official record

www.ema.europa.eu

Indication

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Daptomycin Hospira Authorised · Pfizer Europe MA EEIG

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.