Reason for request

Inclusion

No clinical benefit demonstrated in the topical treatment of mycosis fungoides by comparison with CARYOLYSINE.

  • LEDAGA has marketing authorisation in the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adults.
  • LEDAGA gel has the same active ingredient (chlormethine) and the same indication as CARYOLYSINE cutaneous solution.
  • The non-inferiority of LEDAGA compared with a chlormethine-based preparation has been demonstrated.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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