GARDASIL - GARDASIL - CT 10759 - English version

Has

Description

Introduction GARDASIL, suspension for injection. Human Papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) – vial (glass) – 0.5 ml B/1 (CIP code: 377 143-6) GARDASIL, suspension for injection in a pre-filled syringe. Human Papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) pre filled syringe (glass) – 0.5 ml – Box of 1 pre-filled syringe + 2 needles B/1 (CIP code: 377 130-1) Posted on Feb 01 2012 Active substance (DCI) vaccine against papillomavirus Infectiologie - Mise au point Progrès thérapeutique modéré pour CERVARIX et GARDASIL en prévention des lésions précancéreuses du col de l'utérus dues à HPV 16 et 18Progrès thérapeutique modéré pour GARDASIL en prévention des lésions génitales précancéreuses de la vulve et du vagin dues à HPV 16 et 18 et des condylomes acuminés dus à HPV 6 et 11 Les vaccins CERVARIX et GARDASIL ont l’AMM en prévention des lésions précancéreuses du col de l'utérus dues à certains Papillomavirus (HPV 16 et 18). Cet effet protecteur a été maintenu après 4 ans de suivi. L’effet de ces deux vaccins n’est pas établi en prévention des cancers du col.GARDASIL a aussi l’AMM en prévention des lésions précancéreuses vulvaires et vaginales. Sa composition incluant deux types d’HPV supplémentaires (HPV 6 et 11) par rapport à CERVARIX, il a également un effet protecteur maintenu pendant 4 ans sur les lésions génitales (condylomes) dues aux HPV de génotypes 6 et 11.CERVARIX a une plus grande capacité que GARDASIL à induire une protection croisée vis-à-vis des HPV oncogènes autres que les HPV 16 et 18. Pour en savoir plus, téléchargez la synthèse ou les avis CERVARIX et GARDASIL. ATC Code J07BM01 Laboratory / Manufacturer SANOFI PASTEUR MSD GARDASIL, suspension for injection. Human Papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) – vial (glass) – 0.5 ml B/1 (CIP code: 377 143-6) GARDASIL, suspension for injection in a pre-filled syringe. Human Papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) pre filled syringe (glass) – 0.5 ml – Box of 1 pre-filled syringe + 2 needles B/1 (CIP code: 377 130-1) Posted on Feb 01 2012

Sujets

• Pédiatrie
• Infection sexuellement transmissible
• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 01 février 2012
• Nombre de lectures: 10
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

     

    The legally binding text is the original French document   TRANSPARENCY COMMITTEE   OPINION   1 February 2012     Examination of the dossier for proprietary medicinal products included for a 5-year period starting on 11 July 2007 (Official Gazette of 11 July 2007)   GARDASIL  suspension for injection, Human Papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) – vial (glass) – 0.5 ml B/1 (CIP code: 377 143-6)   GARDASIL  suspension for injection in a pre-filled syringe, Human Papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) pre-filled syringe (glass) – 0.5 ml – Box of 1 pre- filled syringe + 2 needles B/1 (CIP code: 377 130-1)     Applicant: SANOFI PASTEUR MSD   Vaccine against papillomavirus ATC code: J07BM01   List I Date of Marketing Authorisation: 29 September 2006 (Centralised procedure) – Amendment 18 August 2010 and Amendment 1 August 2011   Reasons for request: - Renewal of inclusion on the list of proprietary medicinal products refundable by National Health Insurance. - Further to the submission of new data and new vaccination recommendations from the Haut Conseil de la Santé Publique [High Council for Public Health (HCSP)], reassessment of the improvement in actual benefit, in compliance with Article R163-12 of the French Social Security Code. - Inclusion on the list of medicines refundable by National Health Insurance and on the list of medicines approved for hospital use and various public services in the extension of indication: “premalignant genital lesions of the vagina” .                 Medical, Economic and Public Health Assessment Division

 

1/25

 

1

CHARACTERISTICS OF THE MEDICINAL PRODUCT

    1.1. Active ingredient 1 dose (0.5 ml) contains about: Human Papillomavirus Type 6 L1 protein, 20 micrograms Human Papillomavirus Type 11 L1 protein, 40 micrograms Human Papillomavirus Type 16 L1 protein, 40 micrograms Human Papillomavirus Type 18 L1 protein, 20 micrograms   L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae 3C-5 (Strain 1895)) by recombinant DNA technology, CANADE adsorbed on amorphous aluminium hydroxyphosphate sulphate (225 micrograms) as adjuvant.     1.2. Indications 1   “Gardasil   is a vaccine for use from the age of 9 years for the prevention of:  - premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.  - genital warts (condyloma acuminata) causally related to specific HPV types  - the use of Gardasil should be in accordance with official recommendations” .     1.3. Dosage   “ The primary vaccination series consists of 3 separate 0.5 ml doses administered according to the following schedule: 0, 2, 6 months.   

If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.   

The need for a booster dose has not been established.  Paediatric population: Gardasil has not been used in children under the age of 9 years.    The vaccine should be administered by intramuscular injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.   

It is recommended that individuals who receive a first dose of Gardasil complete the 3-dose vaccination course with Gardasil” 

                                                           1  that section 5.1 of the GARDASIL SPC of 1 August 2011 refers to indications that the HCSP does not Note currently recognise in women aged 24 to 45 or in men aged 16 to 26 (genital warts).     2/25