Xydalba - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

dalbavancin

Opinion

On 27 March 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Xydalba. The marketing authorisation holder for this medicinal product is AbbVie Deutschland GmbH & Co. KG.

The CHMP adopted an extension to the existing indication to include treatment of infants from birth. The full indications of Xydalba will therefore be as follows:¹

Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and olderfrom birth (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

---

¹ New text in bold, removed text as strikethrough.

Key facts

• Name of medicine:
  Xydalba
• EMA 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 therapeutical chemical (ATC) code:
  J01XA04
• Marketing authorisation holder:
  AbbVie Deutschland GmbH & Co. KG
• Date of opinion:
  27/03/2025
• Status:
  Positive