Xydalba

RSS

dalbavancin

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

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.

This EPAR was last updated on 14/12/2022

Authorisation details

Product details
Name
Xydalba
Agency product number
EMEA/H/C/002840
Active substance
dalbavancin hydrochloride
International non-proprietary name (INN) or common name
dalbavancin
Therapeutic area (MeSH)
  • Soft Tissue Infections
  • Skin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code
J01XA04
Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH & Co. KG
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
19/02/2015
Contact address

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
GERMANY

Product information

09/12/2022 Xydalba - EMEA/H/C/002840 - II/0043

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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

Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Assessment history

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