Xydalba
Opinion
On 13 October 2022, 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 for Xydalba to include the treatment of paediatric patients from the age of 3 months.
For information the full indication for Xydalba will be as follows1
Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older (see sections 4.4 and 5.1).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available 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
Key facts
| Name |
Xydalba |
| Agency product number |
EMEA/H/C/002840 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Soft Tissue Infections
Skin Diseases, Bacterial
|
| Date opinion adopted |
13/10/2022 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |