Daptomycin Hospira (daptomycin)
- Region
- 🇪🇺 EU
- Active substance
- daptomycin
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Soft Tissue Infections; Skin Diseases, Bacterial
- CHMP opinion
- Thu 26 Jan 2017
- EU approval
- Wed 22 Mar 2017
- Designations
- Generic
- Application
- EMEA/H/C/004310
- ATC
- J01XX09
- Official record
- www.ema.europa.eu
Indication
Daptomycin 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 isrecommended 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, daptomycin 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
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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.