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PROCYSBI (cysteamine), metabolism medicinal product

Opinions on drugs - Posted on Nov 08 2016

Reason for request

Re-assessment of the improvement in actual benefit

Maintenance of minor clinical added value in the treatment of proven nephropathic cystinosis by comparison with CYSTAGON.


  • PROCYSBI has Marketing Authorisation in the treatment of proven nephropathic cystinosis.
  • The presentation takes the form of prolonged-release gastro-resistant hard capsules, which need to be taken only once every 12 hours. However, better compliance with PROCYSBI relative to CYSTAGON (same active ingredient but with immediate release) cannot be formally established.



Clinical Benefit



Clinical Added Value



Therapeutic use


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