Silgard (human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
- Company
- Merck Sharp Dohme Ltd
- Status
- Withdrawn
- Therapeutic area
- Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization
- EU approval
- Tue 19 Sep 2006
- Application
- EMEA/H/C/000732
- ATC
- J07BM01
- Official record
- www.ema.europa.eu
Indication
Silgard is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Silgard should be in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Gardasil Authorised · Merck Sharp & Dohme B.V.
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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.