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Human papillomavirus vaccine recombinant bivalent - Japan Vaccine/AstraZeneca

Drug Profile

Human papillomavirus vaccine recombinant bivalent - Japan Vaccine/AstraZeneca

Alternative Names: Cervarix; GSK-580299; HPV-16/18 vaccine - Japan Vaccine; Human papillomavirus (types 6, 18) L1 virus-like particle vaccine - Japan Vaccine; Human Papillomavirus 16/18 L1 AS04 virus-like particle cervical cancer vaccine - Japan Vaccine; Human papillomavirus bivalent (types 16, 18) recombinant vaccine - Japan Vaccine; MEDI 517; MEDI-517 HPV-16/18 VLP AS04 vaccine

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator MedImmune
  • Developer GlaxoSmithKline; GSK; Japan Vaccine
  • Class Cancer vaccines; Papillomavirus vaccines; Synthetic vaccines; Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Anal cancer; Cervical cancer; Cervical intraepithelial neoplasia; Human papillomavirus infections
  • Preregistration Submission Withdrawal Head and neck cancer

Most Recent Events

  • 27 May 2022 9370550: updated KDM & HE
  • 27 May 2022 National Medical Products Administration approves human papillomavirus vaccine recombinant bivalent in girls aged between 9 to 14 years for the prevention of cervical cancer, cervical intraepithelial neoplasia and adenocarcinoma in China
  • 22 Oct 2021 Regulatory submission withdrawn for Head and neck cancer (In adolescents, In children, Prevention) in European Union (IM)
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