Reason for request

Extension of indication

No clinical benefit demonstrated in cystinuria

 

  • TROLOVOL has Marketing Authorisation in the treatment of cystinuria.
  • Its assessment in this indication is based on non-comparative studies of poor methodological quality. Its therapeutic benefit compared with tiopronin (ACADIONE) is unknown. The poor safety profile is likely to limit the duration of treatment in some patients.
  • Its dose (300 mg) is not suitable for children under 6 years of age.

 


Clinical Benefit

Low

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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