Is Oritavancin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Oritavancin, including Orbactiv (400 mg, Powder for concentrate for solution for infusion, SAR 7344.75).

Is Oritavancin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Oritavancin: Tenkasi (previously Orbactiv).

Active substance

Oritavancin

SFDA 1
EMA 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Orbactiv	400 mg	Powder for concentrate for solution for infusion · Intravenous use	3 Vial	SAR 7344.75	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

EMA European Union — centrally authorised medicines

Tenkasi (previously Orbactiv) Menarini International Operations Luxembourg S.A. · Authorised · authorised 19 Mar 2015 · ATC J01XA05

Therapeutic indication (EMA)

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.

Ramvocid Targanta Netherlands B.V. · Application withdrawn

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.