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COLTRAMYL and thiocolchicoside generics, muscle relaxant

Opinions on drugs - Posted on Nov 03 2016

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Insufficient actual benefit in the management of painful muscle contractures associated with acute low back pain


  • COLTRAMYL has Marketing Authorisation in the adjuvant treatment for painful contractures in acute lumbar pain.
  • Its efficacy is at best modest.
  • A risk of aneuploidy, known to be a potential risk factor for cancer and for teratogenicity, embryotoxicity, spontaneous abortion and impaired male fertility, has been associated with its use.
  • Considering that alternatives exist for which this risk has not been demonstrated, the clinical interest of thiocolchicoside is henceforth insufficient to justify its reimbursement.




Clinical Benefit



Therapeutic use


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