Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1597967
Name of medicinal product: ADCETRIS
Active substances:
Brentuximab vedotin
Estonian, English, Latin
ATC code: L01FX05
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 50mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Hodgkin lymphoma ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1). ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Systemic anaplastic large cell lymphoma ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL. Cutaneous T-cell lymphoma ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: June 30, 2022
Marketing authorization holder: Takeda Pharma A/S 
Marketing authorization number: EU/1/12/794 
Marketing authorization issued on: October 25, 2012 
Marketing authorization expires on: May 25, 2027 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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