Deltyba

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delamanid

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

Overview

An overview of Deltyba and why it is authorised in the EU

Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines). It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.

Deltyba contains the active substance delamanid.

Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 1 February 2008.

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Deltyba
Agency product number
EMEA/H/C/002552
Active substance
Delamanid
International non-proprietary name (INN) or common name
delamanid
Therapeutic area (MeSH)
Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code
J04AK06
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
Otsuka Novel Products GmbH
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
28/04/2014
Contact address
Erika-Mann-Strasse 21
D-80636 München
Germany

Product information

11/06/2018 Deltyba - EMEA/H/C/002552 - IAIN/0031

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

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

ANTIMYCOBACTERIALS

Therapeutic indication

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug 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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