Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Tremfya   
Auth. number : EU/1/17/1234
Active substance : Guselkumab
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: L04AC - Interleukin inhibitors
(See WHO ATC Index)
Indication: Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
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
14/11/2017 Centralised - Authorisation EMEA/H/C/4271 (2017)7649 of 10/11/2017
12/07/2018 Centralised - Variation EMEA/H/C/4271/II/2/G
12/10/2018 Centralised - Notification EMEA/H/C/4271/N/6
26/11/2018 Centralised - Variation EMEA/H/C/004271/IB/0007
14/02/2019 Centralised - Variation EMEA/H/C/004271/II/0005