Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Yescarta   
Auth. number : EU/1/18/1299
Active substance : axicabtagene ciloleucel
Orphan market exclusivity for "Treatment of diffuse large B cell lymphoma" (based on designation EU/3/14/1393) started on 27/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/08/2028
Orphan market exclusivity for "Treatment of primary mediastinal large B-cell lymphoma" (based on designation EU/3/15/1553) started on 27/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/08/2028
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01X - Other antineoplastic agents
Chemical substance: L01X - Other antineoplastic agents
(See WHO ATC Index)
Indication: YESCARTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Marketing Authorisation Holder: Kite Pharma EU B.V.
Science Park 408, 1098 XH Amsterdam, Nederland

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
27/08/2018 Centralised - Authorisation EMEA/H/C/4480 (2018)5718 of 23/08/2018
19/10/2018 Centralised - Variation EMEA/H/C/4480/IAIN/1
14/01/2019 Centralised - Variation EMEA/H/C/4480/IB/02