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GARDASIL

Active substance (DCI)
  • Human Papillomavirus type 6 L1 Protein
  • Human Papillomavirus type 11 L1 Protein
  • Human Papillomavirus type 16 L1 Protein
  • Human Papillomavirus type 18 L1 Protein

Reason for request
Inclusion on the list of medicines reimbursed by National Insurance and approved for use by hospitals (pack of 1) and inclusion on the list of medicines approved for use by hospitals (pack of 10)

Date 18 April 2007

Actual benefit

Important Le service médical rendu par ce vaccin est important pour la prévention des dysplasies de haut grade du col de l'utérus (CIN 2/3), des cancers du col de l'utérus, des dysplasies de haut grade de la vulve (VIN 2/3) et des verrues génitales externes (condylomes acuminés) dus aux Papillomavirus Humains de types 6, 11, 16 et 18.


Improvement in actual benefit

III (modéré) la Commission considère que le vaccin GARDASIL apporte une amélioration du service médical rendu modérée (niveau III) dans la stratégie de prévention des lésions pré-cancéreuses et cancéreuses du col de l'utérus, des dysplasies de haut grade de la vulve et des verrues génitales externes dans les populations recommandées par le Comité Technique des Vaccinations et le Conseil Supérieur d'Hygiène Publique de France (avis du 9 mars 2007).


Documents

ATC Code
  • J07BM01
Laboratory / Manufacturer
SANOFI PASTEUR MSD

Presentation

GARDASIL, suspension for injection, Human Papillomavirus
[types 6, 11, 16, 18] vaccine (recombinant, adsorbed) – vial (glass) – 0.5 ml
Pack of 1 vial (CIP 377 143-6)
GARDASIL, suspension for injection in prefilled syringe, Human Papillomavirus
[types 6, 11, 16, 18] vaccine (recombinant, adsorbed) prefilled syringe (glass) – 0.5 ml
Pack of 1 prefilled syringe + 2 needles (CIP 377 130-1)
GARDASIL, suspension for injection in prefilled syringe, Human Papillomavirus
[types 6, 11, 16, 18] vaccine (recombinant, adsorbed) prefilled syringe (glass) – 0.5 ml
Pack of 1 prefilled syringe with needle guard device + 2 needles (CIP 377 133-0)
GARDASIL, suspension for injection in prefilled syringe, Human Papillomavirus
[types 6, 11, 16, 18] vaccine (recombinant, adsorbed) prefilled syringe (glass) – 0.5 ml
Pack of 10 prefilled syringes with needle guard device + 20 needles (CIP 570 100-3)

Posted on Apr 18 2007

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