CYSTADANE

This brand name is authorized in Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States

Active ingredients

The drug CYSTADANE contains one active pharmaceutical ingredient (API):

1 Betaine UNII 3SCV180C9W - BETAINE

Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e. CBS deficiency; MTHFR deficiency and cbl defect. The extent of this effect was dependent on the absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia. Betaine anhydrous acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria. Read about Betaine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
CYSTADANE Oral powder	European Medicines Agency (EU)	MPI, EU: SmPC
CYSTADANE Powder for oral solution	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A16AA06	Betaine	A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AA Amino acids and derivatives
Discover more medicines within A16AA06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10119N
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 576920010000107
Country: CA	Health Products and Food Branch	Identifier(s): 02238526
Country: EE	Ravimiamet	Identifier(s): 1286197
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 06379001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 108697
Country: FR	Base de données publique des médicaments	Identifier(s): 63022907
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 135829
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4020
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999035A1028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1028362
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 84352
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18691
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100023966
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W51849001
Country: US	FDA, National Drug Code	Identifier(s): 52276-400