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/1.68 MB)
First published: 22/01/2019
Last updated: 23/04/2021
Authorisation details
Product details | |
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Name |
Sivextro
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Agency product number |
EMEA/H/C/002846
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Active substance |
tedizolid phosphate
|
International non-proprietary name (INN) or common name |
tedizolid phosphate
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J01XX11
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Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
21
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Date of issue of marketing authorisation valid throughout the European Union |
23/03/2015
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Contact address |
Waarderweg 39 |
Product information
27/03/2023 Sivextro - EMEA/H/C/002846 - N/0050
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Antibacterials for systemic use
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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.