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GARDASIL 9, 9-valent human papillomavirus vaccine

INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Mar 29 2018

Reason for request

Inclusion

Substantial clinical benefit in the prevention of precancerous and cancerous anogenital lesions, but no clinical benefit demonstrated compared with GARDASIL

  

  • GARDASIL 9 has Marketing Authorisation in active immunisation against diseases related to certain human papillomaviruses (HPV): genital warts and precancerous and cancerous lesions of the cervix, vulva, vagina and anus.
  • Its composition includes five additional types of HPV (HPV 31, 33, 45, 52 and 58) compared to GARDASIL, which it is intended to replace.
  • It induces an immune response comparable to that of GARDASIL as far as the primary HPV pathogens (HPV 6, 11, 16 and 18) and its efficacy in terms of prevention of cancers remains to be 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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