Xydalba
dalbavancin
Table of contents
Overview
Xydalba is an antibiotic used in adults and children aged 3 months and older 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 dalbavancin.
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List item
Xydalba : EPAR - Summary for the public (PDF/120.31 KB)
First published: 05/03/2015
Last updated: 14/12/2022
EMA/847538/2022 -
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List item
Xydalba : EPAR - Risk-management-plan summary (PDF/136.29 KB)
First published: 05/03/2015
Last updated: 14/12/2022
EMA/16882/2015
Authorisation details
Product details | |
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Name |
Xydalba
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Agency product number |
EMEA/H/C/002840
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Active substance |
dalbavancin hydrochloride
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International non-proprietary name (INN) or common name |
dalbavancin
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J01XA04
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Publication details | |
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Marketing-authorisation holder |
AbbVie Deutschland GmbH & Co. KG
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
19/02/2015
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Contact address |
AbbVie Deutschland GmbH & Co. KG |
Product information
09/12/2022 Xydalba - EMEA/H/C/002840 - II/0043
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
Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.