Xydalba (dalbavancin)
- Region
- 🇪🇺 EU
- Active substance
- dalbavancin
- Company
- AbbVie Deutschland GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Soft Tissue Infections; Skin Diseases, Bacterial
- CHMP opinion
- Thu 18 Dec 2014
- EU approval
- Thu 19 Feb 2015
- Application
- EMEA/H/C/002840
- ATC
- J01XA04
- Official record
- www.ema.europa.eu
Indication
Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.