This is a summary of the European public assessment report (EPAR) for Adcetris. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adcetris.
Adcetris : EPAR - Summary for the public (PDF/114.85 KB)
First published: 22/11/2012
Last updated: 01/02/2018
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Takeda Pharma A/S
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25/07/2018 Adcetris - EMEA/H/C/002455 - N/0060
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
- following autologous stem cell transplant (ASCT) or
- 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 CD30+ HL at increased risk of relapse or progression following ASCT.
Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 201814/12/2018