EMA — authorised 31 December 2009
- Application: EMEA/H/C/001025
- Marketing authorisation holder: Targanta Netherlands B.V.
- Local brand name: Ramvocid
- Status: withdrawn
🇪🇺 Orbactiv in European Union
EMA authorised Orbactiv on 31 December 2009
Marketing authorisations
EMA — authorised 19 March 2015
- Application: EMEA/H/C/003785
- Marketing authorisation holder: Menarini International Operations Luxembourg S.A.
- Local brand name: Tenkasi (previously Orbactiv)
- 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.
- Status: approved
Orbactiv in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Orbactiv approved in European Union?
Yes. EMA authorised it on 31 December 2009; EMA authorised it on 19 March 2015.
Who is the marketing authorisation holder for Orbactiv in European Union?
Targanta Netherlands B.V. holds the EU marketing authorisation.