Is Betaine 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 Betaine, including Cystadane (1 g, Oral powder, SAR 2064.30).

Is Betaine approved by the US FDA?

Drugs@FDA lists 3 application product lines for Betaine, including CYSTADANE (Prescription); BETAINE (Prescription); BETAINE (Prescription).

Is Betaine authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Betaine: Cystadane, Amversio.

Are there safety signals or safety updates for Betaine?

US FDA: 1 entry (latest 2018-11-06).

Active substance

Betaine

SFDA 1
US FDA 3
EMA 2
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
Cystadane	1 g	Oral powder · Oral use	1 Bottle	SAR 2064.30	NCE · Prescription	Recordati Rare Diseases	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CYSTADANE	1GM/SCOOPFUL	for solution · oral	RECORDATI RARE	Prescription	25 Oct 1996
BETAINE	1GM/SCOOPFUL	for solution · oral	NOVITIUM PHARMA	Prescription	23 Nov 2021
BETAINE	1GM/SCOOPFUL	for solution · oral	ETON	Prescription	28 Jan 2022

EMA European Union — centrally authorised medicines

Cystadane Recordati Rare Diseases · Authorised · authorised 14 Feb 2007 · ATC A16AA06

Therapeutic indication (EMA)

Adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS); 5,10-methylene-tetrahydrofolate reductase (MTHFR); cobalamin cofactor metabolism (cbl). Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.

Amversio SERB SA · Authorised · authorised 5 May 2022 · ATC A16AA06

Therapeutic indication (EMA)

Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10 methylene tetrahydrofolate reductase (MTHFR), cobalamin cofactor metabolism (cbl).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CYSTADANE	02238526	1 G / 1.7 CC	POWDER FOR SOLUTION · ORAL	RECORDATI RARE DISEASES CANADA INC

Safety signals and safety-related labeling changes

US FDA 6 Nov 2018 CYSTADANE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for betaine →

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.