Is Larotrectinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Larotrectinib, including VITRAKVI (25 mg, Capsule, SAR 13521.75); VITRAKVI (20 mg/ml, Oral solution, SAR 18268.00); VITRAKVI (100 mg, Capsule, SAR 53950.90).

Is Larotrectinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Larotrectinib, including VITRAKVI (Prescription); VITRAKVI (Prescription).

Is Larotrectinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Larotrectinib: Vitrakvi.

Are there safety signals or safety updates for Larotrectinib?

US FDA: 2 entries (latest 2025-04-09).

Active substance

Larotrectinib

SFDA 3
US FDA 2
EMA 1
Health Canada 3
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
VITRAKVI	25 mg	Capsule · Oral use	56 Bottle	SAR 13521.75	NCE · Prescription	BAYER AG	Valid
VITRAKVI	20 mg/ml	Oral solution · Oral use	1 Bottle	SAR 18268.00	NCE · Prescription	BAYER AG	Valid
VITRAKVI	100 mg	Capsule · Oral use	56 Bottle	SAR 53950.90	NCE · Prescription	BAYER AG	Valid

Indications — CHI Daman Drug Formulary

BRAIN CANCERS; Cervical Cancer; COLORECTAL CANCER-ADVANCED/ METASTATIC; ESOPHAGEAL CANCER; GASTRIC CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; NEUROENDOCRINE TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; SOFT TISSUE SARCOMA; THYROID CANCER; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
VITRAKVI	EQ 25MG BASE; EQ 100MG BASE	capsule · oral	BAYER HLTHCARE	Prescription	26 Nov 2018
VITRAKVI	EQ 20MG BASE/ML	solution · oral	BAYER HEALTHCARE	Prescription	26 Nov 2018

EMA European Union — centrally authorised medicines

Vitrakvi Bayer AG · Authorised · authorised 19 Sep 2019 · ATC L01XE53

Therapeutic indication (EMA)

Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VITRAKVI	02490315	25 MG	CAPSULE · ORAL	BAYER INC
VITRAKVI	02490323	100 MG	CAPSULE · ORAL	BAYER INC
VITRAKVI	02490331	20 MG / ML	SOLUTION · ORAL	BAYER INC

Safety signals and safety-related labeling changes

US FDA 9 Apr 2025 VITRAKVI — 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
US FDA 9 Apr 2025 VITRAKVI — 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

All safety entries for larotrectinib →

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.