Procysbi (mercaptamine)
- Region
- 🇪🇺 EU
- Active substance
- mercaptamine
- Company
- Chiesi Farmaceutici S.p.A
- Status
- Authorised
- Therapeutic area
- Cystinosis
- CHMP opinion
- Thu 27 Jun 2013
- EU approval
- Thu 05 Sep 2013
- Application
- EMEA/H/C/002465
- ATC
- A16AA04
- Official record
- www.ema.europa.eu
Indication
Procysbi 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.
Same substance in other markets
- 🇪🇺 Cystadrops Authorised · Recordati Rare Diseases
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- 🇪🇺 Dropcys Refused · Lucane Pharma
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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.