Is Thyrotropin alfa 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 Thyrotropin alfa, including THYROGEN 0.9 mg/ml powder for solution For injection (0.9 mg/ml, powder for solution for injection, SAR 4584.70).

Is Thyrotropin alfa approved by the US FDA?

Drugs@FDA lists 1 application product line for Thyrotropin alfa, including THYROGEN (Prescription).

Is Thyrotropin alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Thyrotropin alfa: Thyrogen.

Are there safety signals or safety updates for Thyrotropin alfa?

US FDA: 1 entry (latest 2020-03-12).

Active substance

Thyrotropin alfa

SFDA 1
US FDA 1
EMA 1
Health Canada 1
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
THYROGEN 0.9 mg/ml powder for solution For injection	0.9 mg/ml	powder for solution for injection · Intramuscular use	2 Vial	SAR 4584.70	Biological · Prescription	Sanofi B.V	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
THYROGEN	1.1MG/VIAL	injectable · injection	GENZYME	Prescription	30 Nov 1998

EMA European Union — centrally authorised medicines

Thyrogen Sanofi Winthrop Industrie · Authorised · authorised 9 Mar 2000 · ATC H01AB01

Therapeutic indication (EMA)

Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST). Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
THYROGEN	02246016	0.9 MG / VIAL	POWDER FOR SOLUTION · INTRAMUSCULAR	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 12 Mar 2020 THYROGEN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for thyrotropin alfa →

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.