Is Polatuzumab vedotin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Polatuzumab vedotin, including Polivy (140 mg, Powder for concentrate for solution for infusion, SAR 45516.85); Polivy (30 mg, Powder for concentrate for solution for infusion, SAR 9280.80).

Is Polatuzumab vedotin approved by the US FDA?

Drugs@FDA lists 1 application product line for Polatuzumab vedotin, including POLIVY (Prescription).

Is Polatuzumab vedotin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Polatuzumab vedotin: Polivy.

Are there safety signals or safety updates for Polatuzumab vedotin?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-03-18).

Active substance

Polatuzumab vedotin

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Polivy	140 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 45516.85	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid
Polivy	30 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 9280.80	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid

Indications — CHI Daman Drug Formulary

DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

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

Product	Strength	Form · route	Applicant	Status	First approved
POLIVY	140MG/VIAL; 30MG/VIAL	powder · intravenous	GENENTECH	Prescription	10 Jun 2019

EMA European Union — centrally authorised medicines

Polivy Roche Registration GmbH · Authorised · authorised 16 Jan 2020 · ATC L01FX14

Therapeutic indication (EMA)

Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant. Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
POLIVY	02499614	140 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED
POLIVY	02515431	30 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 18 Mar 2026 POLIVY — 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 8 May 2025 PRAC signal: Infusion site extravasation
Action for MAH: update of the product information: No

All safety entries for polatuzumab 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.