Sivextro

RSS

tedizolid phosphate

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

Overview

Sivextro is an antibiotic used in patients from 12 years of age to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (infection of the skin and the tissue underneath), skin abscesses (a swollen area on the skin where pus has collected) and wound infections.

Before using Sivextro, doctors should consider official guidance on the appropriate use of antibiotics.

Sivextro contains the active substance tedizolid.

This EPAR was last updated on 16/03/2022

Authorisation details

Product details
Name
Sivextro
Agency product number
EMEA/H/C/002846
Active substance
tedizolid phosphate
International non-proprietary name (INN) or common name
tedizolid phosphate
Therapeutic area (MeSH)
  • Soft Tissue Infections
  • Skin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code
J01XX11
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
23/03/2015
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

14/03/2022 Sivextro - EMEA/H/C/002846 - IA/0047/G

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antibacterials for systemic use

  • Other antibacterials

Therapeutic indication

Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.

Assessment history

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