Overview
Human papillomavirus type 18 L1 capsid protein antigen is contained in Gardasil, or a recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) vaccine for intramuscular injection. It is an immunization for young men and women 9-26 years of age for the prevention of diseases caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18, which are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs.
Indication
No indication information available.
Associated Conditions
- Human Papillomavirus (HPV) Infections
- Infection caused by human papillomavirus type 18
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-4958 | INTRAMUSCULAR | 40 ug in 0.5 mL | 5/15/2025 | |
| Merck Sharp & Dohme LLC | 0006-4119 | INTRAMUSCULAR | 40 ug in 0.5 mL | 3/25/2025 | |
| Merck Sharp & Dohme LLC | 0006-4121 | INTRAMUSCULAR | 40 ug in 0.5 mL | 3/25/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/20/2007 | ||
Authorised | 9/20/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Gardasil™ Vaccine Syringe | SIN13228P | SOLUTION, STERILE | 20 mcg | 12/5/2006 | |
| Gardasil™ Vaccine Vial | SIN13227P | SOLUTION, STERILE | 20 mcg | 12/5/2006 | |
| GARDASIL 9 SUSPENSION FOR INJECTION | SIN15141P | INJECTION, SUSPENSION | 40 mcg | 12/16/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| GARDASIL | Merck Canada Inc | 02283190 | Suspension - Intramuscular | 20 MCG / 0.5 ML | 8/16/2006 |
| GARDASIL 9 | Merck Canada Inc | 02437058 | Suspension - Intramuscular | 40 MCG / 0.5 ML | 3/18/2015 |
| CERVARIX | 02342227 | Suspension - Intramuscular | 20 MCG / 0.5 ML | 2/10/2010 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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