Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: ADCETRIS   
Auth. number : EU/1/12/794
INN : Brentuximab vedotin
Orphan status based on designation EU/3/08/595 added on 30/10/2012
Orphan status based on designation EU/3/08/596 added on 30/10/2012
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC12 - Brentuximab vedotin
(See WHO ATC Index)
Indication: ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
1. following autologous stem cell transplant (ASCT) or
2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Marketing Authorisation Holder: Takeda Pharma A/S
Langebjerg 1, DK-4000 Roskilde, 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
30/10/2012 Centralised - Authorisation EMEA/H/C/2455 (2012)7764 of 25/10/2012
21/02/2013 Centralised - Variation EMEA/H/C/2455/II/2
Updated with Decision(2013)5596 of 26/08/2013
08/05/2013 Centralised - Variation EMEA/H/C/2455/IAin/4
Updated with Decision(2013)5596 of 26/08/2013
28/08/2013 Centralised - Annual renewal EMEA/H/C/2455/R/5 (2013)5596 of 26/08/2013
28/10/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2455/T/6 (2013)7203 of 24/10/2013
21/11/2013 Centralised - Variation EMEA/H/C/2455/II/7, 8
Updated with Decision(2014)6095 of 22/08/2014
23/01/2014 Centralised - Variation EMEA/H/C/2455/II/9, 11
Updated with Decision(2014)6095 of 22/08/2014
20/03/2014 Centralised - Variation EMEA/H/C/2455/II/10
Updated with Decision(2014)6095 of 22/08/2014
26/06/2014 Centralised - Variation EMEA/H/C/2455/II/12
Updated with Decision(2014)6095 of 22/08/2014
24/07/2014 Centralised - Variation EMEA/H/C/2455/II/18
26/08/2014 Centralised - Annual renewal EMEA/H/C/2455/R/17 (2014)6095 of 22/08/2014
20/11/2014 Centralised - Variation EMEA/H/C/2455/II/20