Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kyntheum   
Auth. number : EU/1/16/1155
Active substance : brodalumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC12 - brodalumab
(See WHO ATC Index)
Indication: Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Marketing Authorisation Holder: Leo Pharma A/S
Industriparken 55, 2750 Ballerup, 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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/07/2017 Centralised - Authorisation EMEA/H/C/3959 (2017)5162 of 17/07/2017
12/09/2017 Centralised - Variation EMEA/H/C/3959/IB/1/G
Updated with Decision(2018)5383 of 02/08/2018
6/08/2018 Centralised - Yearly update (2018)5383 of 2/08/2018
3/10/2018 Centralised - Variation EMEA/H/C/3959/IB/05/G