This is a summary of the European public assessment report (EPAR) for Gardasil 9. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Gardasil 9. For practical information about using Gardasil 9, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
N/AATC Code
J07BM03
ATC Item
papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58)
Pharmacotherapeutic Group
Papillomavirus vaccines
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) | N/A | human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) |
EMA Name
Gardasil 9
Medicine Name
Gardasil 9
Aliases
N/ANo risk management plan link.
