Cystagon (mercaptamine bitartrate)
- Region
- 🇪🇺 EU
- Active substance
- mercaptamine bitartrate
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Cystinosis
- EU approval
- Mon 23 Jun 1997
- Application
- EMEA/H/C/000125
- ATC
- A16AA04
- Official record
- www.ema.europa.eu
Indication
Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.