Is Lenvatinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Lenvatinib, including LENVIMA 10 mg HARD CAPSULES (10 mg, Capsule, hard, SAR 5161.85); LENVIMA 4 mg HARD CAPSULES (4 mg, Capsule, hard, SAR 5161.85); Lenvatinib BOS (10 mg, Capsule, hard, SAR 4817.75); Lenvatinib BOS (4 mg, Capsule, hard, SAR 4817.75).

Is Lenvatinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Lenvatinib, including LENVIMA (Prescription); LENVATINIB (Prescription).

Is Lenvatinib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Lenvatinib: Lenvima, Kisplyx.

Are there safety signals or safety updates for Lenvatinib?

EMA PRAC: 10 entries; US FDA: 1 entry (latest 2026-09-24).

Active substance

Lenvatinib

SFDA 4
US FDA 2
EMA 2
Health Canada 8
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LENVIMA 10 mg HARD CAPSULES	10 mg	Capsule, hard · Oral use	30 Blister	SAR 5161.85	NCE · Prescription	EISAI EUROPE LIMITED	Valid
LENVIMA 4 mg HARD CAPSULES	4 mg	Capsule, hard · Oral use	30 Blister	SAR 5161.85	NCE · Prescription	EISAI EUROPE LIMITED	Valid
Lenvatinib BOS	10 mg	Capsule, hard · Oral use	30 Blister	SAR 4817.75	Generic · Prescription	Boston Oncology Arabia	Valid
Lenvatinib BOS	4 mg	Capsule, hard · Oral use	30 Blister	SAR 4817.75	Generic · Prescription	Boston Oncology Arabia	Valid

Indications — CHI Daman Drug Formulary

ENDOMETRIAL CANCER; HEPATOCELLULAR CARCINOMA; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; THYROID CANCER-ANAPLASTIC CARCINOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
LENVIMA	EQ 4MG BASE; EQ 10MG BASE	capsule · oral	EISAI INC	Prescription	13 Feb 2015
LENVATINIB	4MG; 10MG	capsule · oral	SUN PHARM INDS INC	Prescription

EMA European Union — centrally authorised medicines

Lenvima Eisai GmbH · Authorised · authorised 28 May 2015 · ATC L01XE

Therapeutic indication (EMA)

Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.

Kisplyx Eisai GmbH · Authorised · authorised 25 Aug 2016 · ATC L01XE29

Therapeutic indication (EMA)

Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LENVIMA	02450291	24 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02450305	20 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02450313	14 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02450321	10 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02468220	8 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02468239	18 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02484056	4 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED
LENVIMA	02484129	12 MG / DOSE	CAPSULE · ORAL	EISAI LIMITED

Safety signals and safety-related labeling changes

US FDA 24 Sep 2026 LENVIMA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 16 Jan 2025 PRAC signal: Tumour lysis syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 5 Sep 2024 PRAC signal: Tumour lysis syndrome
Action for MAH: update of the product information: No
EMA PRAC 12 May 2023 PRAC signal: Adrenal insufficiency
Action for MAH: update of the product information: Yes
EMA PRAC 13 Jan 2023 PRAC signal: Adrenal insufficiency
Action for MAH: update of the product information: No
EMA PRAC 28 Oct 2021 PRAC signal: Colitis
Action for MAH: update of the product information: Yes
EMA PRAC 10 Jun 2021 PRAC signal: Colitis
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2016 PRAC signal: Cholecystitis
Action for MAH: update of the product information: No

All safety entries for lenvatinib →

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.