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dalbavancin

Xydalba · ATC code J01XA04

Brand names: Xydalba, Dalbavancin Accord, Dalbavancin Baxter, Dalbavancin Ratiopharm, Dalbavancin Zentiva

Key facts
Active substance
dalbavancin
Drug class
Glycopeptide antibiotic
ATC code
J01XA04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Xydalba 500 mg powder for concentrate for solution for infusion
Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Information as of
2026-10-27

Key facts

Dalbavancin is a glycopeptide antibiotic given by intravenous infusion (Xydalba). It is used to treat acute bacterial skin and skin structure infections.

What it is used for

  • Acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth
  • Official guidance on the appropriate use of antibacterial agents should be considered

Dosing

  • Adults: 1,500 mg as a single infusion, or 1,000 mg followed one week later by 500 mg
  • Children (single dose): birth to less than 6 years 22.5 mg/kg, 6 to less than 18 years 18 mg/kg (maximum 1,500 mg each)
  • Adults with creatinine clearance < 30 ml/min not on regular haemodialysis: 1,000 mg single infusion, or 750 mg followed one week later by 375 mg
  • No adjustment in mild or moderate renal impairment, regular haemodialysis, the elderly, or mild hepatic impairment
  • Caution in moderate or severe hepatic impairment (no data)
  • Intravenous infusion over 30 minutes after reconstitution and dilution

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Hypersensitivity reactions; caution in patients hypersensitive to other glycopeptides (cross-hypersensitivity possible)
  • Clostridioides difficile-associated diarrhoea, up to pseudomembranous colitis; medicines that suppress peristalsis must not be used
  • Infusion-related reactions (flushing, urticaria, pruritus, rash) with rapid infusion

Side effects

  • Most common: nausea, diarrhoea and headache, generally mild or moderate
  • Uncommon include vulvovaginal mycotic infection, urinary tract infection, anaemia, dizziness, flushing, phlebitis
  • Rare: anaphylactoid reaction, bronchospasm

Interactions

  • No clinical interaction studies; not metabolised by CYP enzymes
  • Inhibitors of hepatic transporters (e.g. boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin, cyclosporine) may increase exposure

Pregnancy and breastfeeding

  • Pregnancy: no human data, reproductive toxicity in animals; not recommended unless the expected benefit clearly justifies the risk
  • Breast-feeding: unknown whether excreted in human milk (excreted in rat milk); a benefit-risk decision is required

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • XydalbaAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/002840

Source: European Medicines Agency (EMA), product information

Austria

  • DalbavancinAdvanz Pharma Limited, Baxter Holding B.V., Teva B.V, Tillomed Malta Ltd, Newbury Pharmaceuticals Ab, Rokitan Gmbh, Zentiva, K.S., Accord Healthcare B.V., Reddy Holding Gmbh · 9 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Dalbavancin AccordAccord Healthcare B.V. · 1 register entry
  • Dalbavancin BaxterBaxter Holding B.V. · 1 register entry
  • Dalbavancin RatiopharmRatiopharm Gmbh · 1 register entry
  • Dalbavancin ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Brand names in 17 more European countries
Belgium
Dalbavancin Baxter, Dalbavancine Baxter
Denmark
Dalbavancin Adalvo, Dalbavancin Baxter, Dalbavancin Teva, Dalbavancin Tillomed
Finland
Dalbavancin Adalvo, Dalbavancin Baxter, Dalbavancin Tillomed
France
Dalbavancine
Greece
Bavalda, Dalbavancin Accord, Dalbavancin Anfarm, Dalbavancin Bioars, Dalbavancin Teva
Iceland
Xydalba
Italy
Dalbavancina
Liechtenstein
Xydalba
Luxembourg
Dalbavancin, Dalbavancine
Malta
Bavalda, Dalbavancin Adalvo, Dalbavancin Advanz Pharma, Dalbavancin Anfarm, Dalbavancin Bioars, Dalbavancin Diagonalis, Dalbavancin Zentiva
Netherlands
Dalbavancine Baxter
Norway
Dalbavancin, Xydalba
Poland
Dalbavancin Accord, Dalbavancin Reig Jofre
Portugal
Dalbavancina Anfarm
Slovakia
Dalbavancin Adalvo
Spain
Dalbavancin Dr. Reddys, Dalbavancina Accord, Dalbavancina Advanz Pharma, Dalbavancina Baxter, Dalbavancina Sala, Dalbavancina Teva, Dalbavancina Tillomed, Dalbavancina Zentiva
Sweden
Dalbavancin

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Xydalba – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xydalba-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. Wikidata (CC0): ATC J01XA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.