Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kyprolis   
Auth. number : EU/1/15/1060
Active substance : carfilzomib
Orphan market exclusivity for "Treatment of multiple myeloma" (based on designation EU/3/08/548) started on 23/11/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/11/2025
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: L01XX45 - carfilzomib
(See WHO ATC Index)
Indication: Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Marketing Authorisation Holder: Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland
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
23/11/2015 Centralised - Authorisation EMEA/H/C/3790 (2015)8267 of 19/11/2015
13/01/2016 Corrigendum (2015)8267 of 19/11/2015
25/02/2016 Centralised - Variation EMEA/H/C/3790/II/2/G
Updated with Decision(2016)4191 of 29/06/2016
28/04/2016 Centralised - Variation EMEA/H/C/3790/II/4/G
Updated with Decision(2016)4191 of 29/06/2016
1/07/2016 Centralised - 2-Monthly update EMEA/H/C/3790/II/1/G (2016)4191 of 29/06/2016
4/08/2016 Centralised - Variation EMEA/H/C/3790/II/6
Updated with Decision(2016)8648 of 12/12/2016
10/08/2016 Corrigendum (2016)4191 of 29/06/2016
8/11/2016 Centralised - Variation EMEA/H/C/3790/IB/8
Updated with Decision(2016)8648 of 12/12/2016
14/12/2016 Centralised - 2-Monthly update EMEA/H/C/3790/II/7/G (2016)8648 of 12/12/2016
10/03/2017 Centralised - Variation EMEA/H/C/3790/IA/11
Updated with Decision(2017)7743 of 15/11/2017
10/11/2017 Centralised - Variation EMEA/H/C/3790/IG/853
Updated with Decision(2018)2493 of 19/04/2018
17/11/2017 PSUSA - Modification EMEA/H/C/PSUSA/10448/201701 (2017)7743 of 15/11/2017
25/01/2018 Centralised - Variation EMEA/H/C/3790/II/17/G
Updated with Decision(2018)2493 of 19/04/2018
23/04/2018 PSUSA - Modification EMEA/H/C/3790/PSUSA/10448/201707 (2018)2493 of 19/04/2018
26/04/2018 Centralised - Variation EMEA/H/C/3790/II/25
Updated with Decision(2018)7965 of 22/11/2018
4/06/2018 Centralised - Variation EMEA/H/C/3790/IG/946
Updated with Decision(2018)7965 of 22/11/2018
20/09/2018 Centralised - Variation EMEA/H/C/3790/II/30
Updated with Decision(2018)7965 of 22/11/2018
26/11/2018 Centralised - Yearly update (2018)7965 of 22/11/2018