Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Authorised
- Therapeutic area
- Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization
- EU approval
- Thu 20 Sep 2007
- Application
- EMEA/H/C/000721
- ATC
- J07BM02
- Official record
- www.ema.europa.eu
Indication
Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Cervarix should be in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.