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EMA Product

Cystagon

Product approved by European Medicines Agency (EU)

Basic Information

Cystagon

Regulatory Information

EMEA/H/C/000125

Authorised

June 23, 1997

20

December 11, 2024

Company Information

France

Immeuble le Wilson 70, avenue du Général de Gaulle 92800 Puteaux

RECORDATI RARE DISEASES

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Cystagon. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cystagon.

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