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Gardasil (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 B.V.

Status

Authorised

Therapeutic area

Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization

CHMP opinion

Thu 27 Jul 2006

EU approval

Wed 20 Sep 2006

Application

EMEA/H/C/000703

ATC

J07BM01

Official record

www.ema.europa.eu

Indication

Gardasil 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 Gardasil should be in accordance with official recommendations.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Silgard Withdrawn · Merck Sharp Dohme Ltd

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.