Tenkasi (previously Orbactiv) (oritavancin)
- Region
- 🇪🇺 EU
- Active substance
- oritavancin
- Company
- Menarini International Operations Luxembourg S.A.
- Status
- Authorised
- Therapeutic area
- Soft Tissue Infections; Skin Diseases, Bacterial
- EU approval
- Thu 19 Mar 2015
- Application
- EMEA/H/C/003785
- ATC
- J01XA05
- Official record
- www.ema.europa.eu
Indication
Tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older (see sections 4.2, 4.4 and 5.1). 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
- 🇪🇺 Ramvocid Application withdrawn · Targanta Netherlands B.V.
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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.