Is Mavacamten 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 Mavacamten, including Camzyos (5 mg, Capsule, hard, SAR 6100.75); Camzyos (10 mg, Capsule, hard, SAR 6100.75); Camzyos (15 mg, Capsule, hard, SAR 6100.75); Camzyos (2.5 mg, Capsule, hard, SAR 6100.75).

Is Mavacamten approved by the US FDA?

Drugs@FDA lists 1 application product line for Mavacamten, including CAMZYOS (Prescription).

Is Mavacamten authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mavacamten: Camzyos.

Are there safety signals or safety updates for Mavacamten?

US FDA: 1 entry (latest 2026-09-30).

Active substance

Mavacamten

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Camzyos	5 mg	Capsule, hard · Oral use	28 Blister	SAR 6100.75	NCE · Prescription	Bristol Myers Squibb Pharma EEIG	Valid
Camzyos	10 mg	Capsule, hard · Oral use	28 Blister	SAR 6100.75	NCE · Prescription	Bristol Myers Squibb Pharma EEIG	Valid
Camzyos	15 mg	Capsule, hard · Oral use	28 Blister	SAR 6100.75	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
Camzyos	2.5 mg	Capsule, hard · Oral use	28 Blister	SAR 6100.75	NCE · Prescription	Bristol Myers Squibb Pharma EEIG	Valid

Indications — CHI Daman Drug Formulary

CARDIOMYOPATHY - OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY

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

Product	Strength	Form · route	Applicant	Status	First approved
CAMZYOS	2.5MG; 5MG; 10MG; 15MG	capsule · oral	BRISTOL	Prescription	28 Apr 2022

EMA European Union — centrally authorised medicines

Camzyos Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 26 Jun 2023 · ATC C01EB

Therapeutic indication (EMA)

Treatment of symptomatic obstructive hypertrophic cardiomyopathy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CAMZYOS	02532549	2.5 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
CAMZYOS	02532557	5 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
CAMZYOS	02532565	10 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
CAMZYOS	02532573	15 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

US FDA 30 Sep 2026 CAMZYOS — 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 mavacamten →

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.