Is Tafamidis 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 Tafamidis, including Vyndamax (61 mg, Capsule, soft, SAR 39840.55).

Is Tafamidis approved by the US FDA?

Drugs@FDA lists 2 application product lines for Tafamidis, including VYNDAMAX (Prescription); VYNDAQEL (Discontinued).

Is Tafamidis authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Tafamidis: Vyndaqel, Tafamidis Accord.

Are there safety signals or safety updates for Tafamidis?

US FDA: 2 entries (latest 2023-10-17).

Active substance

Tafamidis

SFDA 1
US FDA 2
EMA 2
Health Canada 2
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
Vyndamax	61 mg	Capsule, soft · Oral use	30 Blister	SAR 39840.55	NCE · Prescription	PFIZER INC	Valid

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS- WILD-TYPE TRANSTHYRETIN-RELATED (ATTR); CARDIOMYOPATHY

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

Product	Strength	Form · route	Applicant	Status	First approved
VYNDAMAX	61MG	capsule · oral	FOLDRX PHARMS	Prescription	3 May 2019
VYNDAQEL	20MG	capsule · oral	FOLDRX PHARMS	Discontinued	3 May 2019

EMA European Union — centrally authorised medicines

Vyndaqel Pfizer Europe MA EEIG · Authorised · authorised 16 Nov 2011 · ATC N07XX08

Therapeutic indication (EMA)

Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.

Tafamidis Accord Accord Healthcare S.L.U. · Authorised · authorised 18 Sep 2026 · ATC N07XX08

Therapeutic indication (EMA)

Tafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRh-CM).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VYNDAMAX	02517841	61 MG	CAPSULE · ORAL	PFIZER CANADA ULC
VYNDAQEL	02495732	20 MG	CAPSULE · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 17 Oct 2023 VYNDAMAX — safety-related labeling change
Labeling sections changed: Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Oct 2023 VYNDAQEL — safety-related labeling change
Labeling sections changed: Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tafamidis →

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.