Tenkasi (previously Orbactiv)
oritavancin
Table of contents
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.
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Tenkasi (previously Orbactiv) : EPAR - Medicine overview (PDF/148.5 KB)
First published: 04/05/2015
Last updated: 24/05/2023
EMA/167280/2023 -
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Tenkasi (previously Orbactiv) : EPAR - Risk-management-plan summary (PDF/48.59 KB)
First published: 04/05/2015
Last updated: 22/09/2023
Authorisation details
Product details | |
---|---|
Name |
Tenkasi (previously Orbactiv)
|
Agency product number |
EMEA/H/C/003785
|
Active substance |
oritavancin (diphosphate)
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International non-proprietary name (INN) or common name |
oritavancin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J01XA05
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Publication details | |
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Marketing-authorisation holder |
Menarini International Operations Luxembourg S.A.
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Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
19/03/2015
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Contact address |
1, Avenue de la Gare |
Product information
15/09/2023 Tenkasi (previously Orbactiv) - EMEA/H/C/003785 - X/0036
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.