Is Trientine tetrahydrochloride 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 Trientine tetrahydrochloride, including Cuprior (150 mg, Film-coated tablet, SAR 7303.80).

Is Trientine tetrahydrochloride approved by the US FDA?

Drugs@FDA lists 1 application product line for Trientine tetrahydrochloride, including CUVRIOR (Prescription).

Is Trientine tetrahydrochloride authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Trientine tetrahydrochloride: Cuprior.

Active substance

Trientine tetrahydrochloride

SFDA 1
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cuprior	150 mg	Film-coated tablet · Oral use	72 Blister	SAR 7303.80	NCE · Prescription	Orphalan	Valid

Indications — CHI Daman Drug Formulary

WILSON'S DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
CUVRIOR	300MG	tablet · oral	ORPHALAN	Prescription	28 Apr 2022

EMA European Union — centrally authorised medicines

Cuprior Orphalan · Authorised · authorised 5 Sep 2017 · ATC A16AX

Therapeutic indication (EMA)

Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.

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.