Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Recordati Rare Diseases, Tour Hekla, 52 avenue du Général de Gaulle, F-92 800 Puteaux, France
Cystadane 1 g oral powder.
| Pharmaceutical Form |
|---|
|
Oral powder. White crystalline free flowing powder. |
1 g of powder contains 1 g of betaine anhydrous.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
None. |
HDPE bottles with a child resistant closure.
Each pack contains 1 bottle with 180 g of powder and three measuring spoons.
Recordati Rare Diseases, Tour Hekla, 52 avenue du Général de Gaulle, F-92 800 Puteaux, France
EU/1/06/379/001
Date of first authorisation: 15 February 2007
Date of latest renewal: 21 November 2016
| Drug | Countries | |
|---|---|---|
| CYSTADANE | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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