Is Vortioxetine 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 Vortioxetine, including BRINTELLIX 10 mg film-coated tablet (10 mg, Film-coated tablet, SAR 140.65); BRINTELLIX 20 mg film-coated tablet (20 mg, Film-coated tablet, SAR 234.40).

Is Vortioxetine approved by the US FDA?

Drugs@FDA lists 3 application product lines for Vortioxetine, including TRINTELLIX (Prescription); TRINTELLIX (Discontinued); VORTIOXETINE HYDROBROMIDE (Discontinued).

Is Vortioxetine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vortioxetine: Brintellix.

Are there safety signals or safety updates for Vortioxetine?

EMA PRAC: 14 entries; US FDA: 1 entry (latest 2026-06-11).

Active substance

Vortioxetine

SFDA 2
US FDA 3
EMA 1
Health Canada 6
US price lines 3
NHS prices 3
Safety 15

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BRINTELLIX 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 140.65	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
BRINTELLIX 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 234.40	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid

Indications — CHI Daman Drug Formulary

ANXIETY DISORDERS; AUTISM SPECTRUM DISORDER; DEPRESSION

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

Product	Strength	Form · route	Applicant	Status	First approved
TRINTELLIX	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	TAKEDA PHARMS USA	Prescription	30 Sep 2013
TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	TAKEDA PHARMS USA	Discontinued	30 Sep 2013
VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ZYDUS PHARMS	Discontinued

EMA European Union — centrally authorised medicines

Brintellix H. Lundbeck A/S · Authorised · authorised 18 Dec 2013 · ATC N06AX26

Therapeutic indication (EMA)

Treatment of major depressive episodes in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-VORTIOXETINE	02552744	5 MG	TABLET · ORAL	APOTEX INC
APO-VORTIOXETINE	02552752	10 MG	TABLET · ORAL	APOTEX INC
APO-VORTIOXETINE	02552779	20 MG	TABLET · ORAL	APOTEX INC
TRINTELLIX	02432919	5 MG	TABLET · ORAL	LUNDBECK CANADA INC
TRINTELLIX	02432927	10 MG	TABLET · ORAL	LUNDBECK CANADA INC
TRINTELLIX	02432943	20 MG	TABLET · ORAL	LUNDBECK CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRINTELLIX 10 MG TABLET	$17.19738	per EA	23 Sep 2026
US NADAC	TRINTELLIX 20 MG TABLET	$17.19979	per EA	23 Sep 2026
US NADAC	TRINTELLIX 5 MG TABLET	$17.19677	per EA	23 Sep 2026
NHS Drug Tariff	Vortioxetine 10mg tablets	£27.72	28 tablet	1 Oct 2026
NHS Drug Tariff	Vortioxetine 20mg tablets	£27.72	28 tablet	1 Oct 2026
NHS Drug Tariff	Vortioxetine 5mg tablets	£27.72	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Acute pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 15 Jan 2026 PRAC signal: Acute pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 5 Jun 2025 PRAC signal: Hallucinations, not related to serotoninergic syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 13 Feb 2025 PRAC signal: Hallucinations, not related to serotoninergic syndrome
Action for MAH: update of the product information: No
US FDA 23 Aug 2023 TRINTELLIX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No
EMA PRAC 10 Mar 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No
EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No
EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes
EMA PRAC 31 Oct 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No
EMA PRAC 12 Apr 2018 PRAC signal: Angioedema and urticaria
Action for MAH: update of the product information: Yes
EMA PRAC 30 Nov 2017 PRAC signal: Angioedema
Action for MAH: update of the product information: No

All safety entries for vortioxetine →

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.