Sivextro

RSS

tedizolid phosphate

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

Overview

This is a summary of the European public assessment report (EPAR) for Sivextro. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Sivextro.

For practical information about using Sivextro, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 22/01/2019

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
J01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
10
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

11/10/2018 Sivextro - EMEA/H/C/002846 - IAIN/0030/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Assessment history

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