Is Tiratricol approved by the US FDA?

Drugs@FDA lists 1 application product line for Tiratricol, including EMCITATE (Prescription).

Is Tiratricol authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tiratricol: Emcitate.

Active substance

Tiratricol

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
EMCITATE	350MCG	tablet · oral	RARE THYROID THERAPEUTICS INTERNATIONAL AB	Prescription	28 Sep 2026

EMA European Union — centrally authorised medicines

Emcitate Rare Thyroid Therapeutics International AB · Authorised · authorised 12 Feb 2025 · ATC H03AA04

Therapeutic indication (EMA)

Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.

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.