Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: ADCETRIS   
Auth. number : EU/1/12/794
Active substance : Brentuximab vedotin
Orphan market exclusivity for "Treatment of anaplastic large cell lymphoma" (based on designation EU/3/08/595) started on 30/10/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 30/10/2022
Orphan market exclusivity for "Treatment of Hodgkin lymphoma" (based on designation EU/3/08/596) started on 30/10/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 30/10/2022
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC12 - Brentuximab vedotin
(See WHO ATC Index)
Indication: Ttreatment 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.
Treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, 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
Updated with Decision(2015)4708 of 03/07/2015
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
Updated with Decision(2015)4708 of 03/07/2015
02/03/2015 Centralised - Variation EMEA/H/C/2455/IAin/24
Updated with Decision(2015)4708 of 03/07/2015
07/07/2015 Centralised - Yearly update (2015)4708 of 03/07/2015
14/09/2015 Centralised - Annual renewal EMEA/H/C/2455/R/26 (2015)6315 of 10/09/2015
23/11/2015 Centralised - 2-Monthly update EMEA/H/C/2455/II/28 (2015)8266 of 19/11/2015
21/12/2015 Centralised - Variation EMEA/H/C/2455/IAIN/29/G
Updated with Decision(2016)4070 of 24/06/2016
15/03/2016 Centralised - Variation EMEA/H/C/2455/IB/34/G
Updated with Decision(2016)4070 of 24/06/2016
01/04/2016 Centralised - Variation EMEA/H/C/2455/II/32
Updated with Decision(2016)4070 of 24/06/2016
28/04/2016 Centralised - Variation EMEA/H/C/2455/II/30/G
Updated with Decision(2016)4070 of 24/06/2016
28/04/2016 Centralised - Variation EMEA/H/C/2455/II/33
Updated with Decision(2016)4070 of 24/06/2016
28/06/2016 Centralised - Variation EMEA/H/C/2455/IB/38
Updated with Decision(2016)6877 of 21/10/2016
28/06/2016 Centralised - 2-Monthly update EMEA/H/C/2455/II/25 (2016)4070 of 24/06/2016
25/10/2016 Centralised - Annual renewal EMEA/H/C/2455/R/35 (2016)6877 of 21/10/2016
14/11/2016 Centralised - Variation EMEA/H/C/2455/IAin/40
14/01/2017 Centralised - Variation EMEA/H/C/2455/IB/44
22/06/2017 Centralised - Variation EMEA/H/C/2455/II/45
19/07/2017 Centralised - Variation EMEA/H/C/2455/IAIN/52