Is Epcoritamab 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 Epcoritamab, including Tepkinly (4 mg/ml, concentrate for solution for injection, SAR 2789.95); Tepkinly (48 mg/ml, Solution for injection, SAR 33479.35).

Is Epcoritamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Epcoritamab, including EPKINLY (Prescription).

Is Epcoritamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Epcoritamab: Tepkinly.

Are there safety signals or safety updates for Epcoritamab?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2026-06-17).

Active substance

Epcoritamab

SFDA 2
US FDA 1
EMA 1
Health Canada 2
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Tepkinly	4 mg/ml	concentrate for solution for injection · Subcutaneous use	1 Vial	SAR 2789.95	Biological · Prescription	ABBVIE Deutschland GmbH	Valid
Tepkinly	48 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 33479.35	Biological · Prescription	ABBVIE Deutschland GmbH	Valid

Indications — CHI Daman Drug Formulary

Diffuse Large B-Cell Lymphoma; FOLLICULAR LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
EPKINLY	4MG/0.8ML; 48MG/0.8ML	injectable · subcutaneous	GENMAB US, INC.	Prescription	19 May 2023

EMA European Union — centrally authorised medicines

Tepkinly AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 22 Sep 2023 · ATC L01FX27

Therapeutic indication (EMA)

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EPKINLY	02542293	5 MG / ML	SOLUTION · SUBCUTANEOUS	ABBVIE CORPORATION
EPKINLY	02542307	60 MG / ML	SOLUTION · SUBCUTANEOUS	ABBVIE CORPORATION

Safety signals and safety-related labeling changes

US FDA 17 Jun 2026 EPKINLY — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 30 Oct 2025 PRAC signal: Hypogammaglobulinaemia
Action for MAH: update of the product information: Yes
EMA PRAC 5 Jun 2025 PRAC signal: Hypogammaglobulinaemia
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2024 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No

All safety entries for epcoritamab →

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.