Ninlaro
ixazomib
Table of contents
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.
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Ninlaro : EPAR - Summary for the public (PDF/77.92 KB)
First published: 07/12/2016
Last updated: 24/10/2017 -
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Ninlaro : EPAR - Risk management plan summary (PDF/119.2 KB)
First published: 11/03/2022
Last updated: 31/03/2022
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 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 |
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 |
Product information
23/08/2023 Ninlaro - EMEA/H/C/003844 - IB/0044/G
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
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.