Xydalba

RSS

dalbavancin

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

Overview

This is a summary of the European public assessment report (EPAR) for Xydalba. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xydalba.

For practical information about using Xydalba, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/01/2020

Authorisation details

Product details
Name
Xydalba
Agency product number
EMEA/H/C/002840
Active substance
dalbavancin hcl
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
Allergan Pharmaceuticals International Ltd
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
19/02/2015
Contact address

Clonshaugh Business & Technology Park
Dublin 17, D17 E400
Ireland

Product information

05/12/2019 Xydalba - EMEA/H/C/002840 - R/0028

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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