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.
Ninlaro : EPAR - Summary for the public (PDF/77.92 KB)
First published: 07/12/2016
Last updated: 24/10/2017
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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.
Takeda Pharma A/S
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19/08/2019 Ninlaro - EMEA/H/C/003844 - IAIN/0018/G
- 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.
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.