This is a summary of the European public assessment report (EPAR) for Gardasil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Gardasil.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
J07BM01
ATC Item
papillomavirus (human types 6, 11, 16, 18)
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| human papillomavirus type 6 L1 protein | N/A | 重组人乳头瘤病毒6型L1蛋白 |
| human papillomavirus type 11 L1 protein | N/A | 重组人乳头瘤病毒11型L1蛋白 |
| human papillomavirus type 16 L1 protein | N/A | 重组人乳头瘤病毒16型L1蛋白 |
| human papillomavirus type 18 L1 protein | N/A | 重组人乳头瘤病毒18型L1蛋白 |
EMA Name
Gardasil
Medicine Name
Gardasil
Aliases
N/ANo risk management plan link.
