Ninlaro

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ixazomib

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

Overview

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

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

This EPAR was last updated on 05/09/2023

Authorisation details

Product details
Name
Ninlaro
Agency product number
EMEA/H/C/003844
Active substance
ixazomib citrate
International non-proprietary name (INN) or common name
ixazomib
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XG03
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.

Conditional approvalConditional 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.

OrphanOrphan

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
Takeda Pharma A/S
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
21/11/2016
Contact address

Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark

Product information

23/08/2023 Ninlaro - EMEA/H/C/003844 - IB/0044/G

Other EU languages available icon 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:

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

Antineoplastic agents

Therapeutic indication

Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Assessment history

Changes since initial authorisation of medicine

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