Sirturo

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bedaquiline

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

Overview

This is a summary of the European public assessment report (EPAR) for Sirturo. 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 Sirturo.

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

This EPAR was last updated on 31/10/2018

Authorisation details

Product details
Name
Sirturo
Agency product number
EMEA/H/C/002614
Active substance
bedaquiline fumarate
International non-proprietary name (INN) or common name
bedaquiline
Therapeutic area (MeSH)
Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code
J04A
Additional 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.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
04/03/2014
Contact address
Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

11/10/2018 Sirturo - EMEA/H/C/002614 - N/0032

Contents

Please note that the size of the above document can exceed 50 pages.

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

Pharmacotherapeutic group

DRUGS FOR TREATMENT OF TUBERCULOSIS

Therapeutic indication

Indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

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