Cystadane (betaine anhydrous)
- Region
- 🇪🇺 EU
- Active substance
- betaine anhydrous
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Homocystinuria
- EU approval
- Wed 14 Feb 2007
- Application
- EMEA/H/C/000678
- ATC
- A16AA06
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Amversio Authorised · SERB SA
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