CYSTADANE

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

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 more about Betaine

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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