Is Brentuximab vedotin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Brentuximab vedotin, including ADCETRIS 50 mg powder for concentrate for solution for infusion (50 mg, Powder for concentrate for solution for infusion, SAR 13071.30).

Is Brentuximab vedotin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Brentuximab vedotin, including ADCETRIS (Prescription); ADCETRIS (Prescription).

Is Brentuximab vedotin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brentuximab vedotin: Adcetris.

Are there safety signals or safety updates for Brentuximab vedotin?

EMA PRAC: 4 entries; US FDA: 1 entry (latest 2025-02-11).

Active substance

Brentuximab vedotin

SFDA 1
US FDA 2
EMA 1
Health Canada 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADCETRIS 50 mg powder for concentrate for solution for infusion	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 13071.30	Biological · Prescription	TAKEDA PHARMA A/S	Valid

Indications — CHI Daman Drug Formulary

DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); HODGKIN'S LYMPHOMA; T-CELL LYMPHOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ADCETRIS	50MG/VIAL	injectable · injection	SEATTLE GENETICS	Prescription	19 Aug 2011
ADCETRIS	50MG/VIAL	injectable · injection	SEATTLE GENETICS	Prescription	19 Aug 2011

EMA European Union — centrally authorised medicines

Adcetris Takeda Pharma A/S · Authorised · authorised 25 Oct 2012 · ATC L01FX05

Therapeutic indication (EMA)

Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).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).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):- following ASCT, or- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T-cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADCETRIS	02401347	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 11 Feb 2025 ADCETRIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 5 May 2017 PRAC signal: Cytomegalovirus (CMV) reactivation
Action for MAH: update of the product information: Yes
EMA PRAC 1 Dec 2016 PRAC signal: Cytomegalovirus (CMV) reactivation
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2013 PRAC signal: Interstitial lung disease, pulmonary alveolar haemorrhage and pulmonary toxicity
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2013 PRAC signal: Interstitial lung disease, pulmonary alveolar haemorrhage and pulmonary toxicity
Action for MAH: update of the product information: No

All safety entries for brentuximab vedotin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.