Is Bupropion + Naltrexone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Bupropion + Naltrexone, including CONTRAVE (90,8 mg,mg, Prolonged-release tablet, SAR 358.45).

Is Bupropion + Naltrexone approved by the US FDA?

Drugs@FDA lists 1 application product line for Bupropion + Naltrexone, including CONTRAVE (Prescription).

Is Bupropion + Naltrexone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bupropion + Naltrexone: Mysimba.

Active substances

Bupropion + Naltrexone

SFDA 1
US FDA 1
EMA 1
Health Canada 1
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CONTRAVE	90,8 mg,mg	Prolonged-release tablet · Oral use	112 Blister	SAR 358.45	NCE · Prescription	Algorithm SAL	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CONTRAVE	90MG;8MG	tablet, extended release · oral	AZURITY	Prescription	10 Sep 2014

EMA European Union — centrally authorised medicines

Mysimba Orexigen Therapeutics Ireland Limited · Authorised · authorised 26 Mar 2015 · ATC A08AA

Therapeutic indication (EMA)

Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CONTRAVE	02472945	8 MG; 90 MG	TABLET (EXTENDED-RELEASE) · ORAL	BAUSCH HEALTH, CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Naltrexone 8mg / Bupropion 90mg modified-release tablets	£73.00	112 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.

Components

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.