Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ninlaro   
Auth. number : EU/1/16/1094
Active substance : ixazomib
Orphan market exclusivity for "Treatment of multiple myeloma" (based on designation EU/3/11/899) started on 23/11/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/11/2026
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX50 - ixazomib
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/11/2016 Centralised - Authorisation EMEA/H/C/3844 (2016)7672 of 21/11/2016
6/07/2017 Centralised - Variation EMEA/H/C/3844/II/2
Updated with Decision(2017)6409 of 18/09/2017
18/07/2017 Centralised - Variation EMEA/H/C/3844/IA/4
Updated with Decision(2018)4463 of 06/07/2018
20/09/2017 Centralised - Annual renewal EMEA/H/C/3844/R/3 (2017)6409 of 18/09/2017
12/12/2017 Centralised - Variation EMEA/H/C/3844/IB/7
Updated with Decision(2018)4463 of 06/07/2018
10/07/2018 Centralised - Yearly update (2018)4463 of 6/07/2018
19/09/2018 Centralised - Annual renewal EMEA/H/C/3844/R/12 (2018)6104 of 17/09/2018
24/09/2018 Corrigendum (2018)4463 of 6/07/2018