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Community Register of medicinal products
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: | 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 |
EPAR and active package presentations
Package presentations
|
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. |
European Commission procedures
| 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 |