Reason for request

Re-assessment of the actual benefit and Renewal of inclusion

Low clinical benefit in the local treatment of vaginitis caused by sensitive bacteria and non-specific vaginitis

  • POLYGYNAX, POLYGYNAX VIRGO and TERGYNAN have Marketing Authorisation in the local treatment of vaginitis caused by sensitive bacteria and non-specific vaginitis.

  • A randomised double-blind trial found no significant difference between POLYGYNAX and miconazole administered by vaginal route(GYNO DAKTARIN) in terms of efficacy in the empirical treatment of infectious vaginitis

  • For TERGYNAN, no new clinical data have been supplied by the company.

 

 


Clinical Benefit

Low

-


Therapeutic use

-

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