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Community Register of medicinal products
Community register of medicinal products for human use
|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:||L - Antineoplastic and immunomodulating agents|
L01 - Cytostatics
L01X - Other cytostatics
L01XC - Monoclonal antibodies
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 Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, United Kingdom
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|