Sivextro
tedizolid phosphate
Table of contents
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.
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List item
Sivextro : EPAR - Medicine overview (PDF/121.85 KB)
First published: 26/03/2015
Last updated: 28/07/2020
EMA/314678/2020 -
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List item
Sivextro : EPAR - Risk-management-plan summary (PDF/1.66 MB)
First published: 22/01/2019
Last updated: 28/07/2020
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) |
|
Anatomical therapeutic chemical (ATC) code |
J01
|
Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
23/03/2015
|
Contact address |
Product information
16/10/2020 Sivextro - EMEA/H/C/002846 - IB/0040
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
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.