Gardasil 9 (human papillomavirus 9-valent vaccine (recombinant, adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- human papillomavirus 9-valent vaccine (recombinant, adsorbed)
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia
- CHMP opinion
- Wed 25 Mar 2015
- EU approval
- Wed 10 Jun 2015
- Application
- EMEA/H/C/003852
- ATC
- J07BM03
- Official record
- www.ema.europa.eu
Indication
Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types Genital warts (Condyloma acuminata) caused by specific HPV types. See sections 4.4 and 5.1 for important information on the data that support these indications. The use of Gardasil 9 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.