Tenkasi (previously Orbactiv)

RSS

oritavancin

Authorised
This medicine is authorised for use in the European Union.

Overview

Tenkasi is an antibiotic used in adults and children from 3 months of age to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections. It contains the active substance oritavancin.

This EPAR was last updated on 08/06/2023

Authorisation details

Product details
Name
Tenkasi (previously Orbactiv)
Agency product number
EMEA/H/C/003785
Active substance
oritavancin diphosphate
International non-proprietary name (INN) or common name
oritavancin
Therapeutic area (MeSH)
  • Soft Tissue Infections
  • Skin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code
J01XA05
Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
19/03/2015
Contact address

1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Product information

15/05/2023 Tenkasi (previously Orbactiv) - EMEA/H/C/003785 - II/0037

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic 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.

Assessment history

Changes since initial authorisation of medicine

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