| Product Information |
|
| Registration Number |
BR-1214
|
| Generic Name |
Human Papillomavirus 9-Valent Vaccine (Recombinant,
Adsorbed)
|
| Brand Name |
Gardasil 9
|
| Dosage Strength |
Formulation: Each dose (0.5 mL) contains:
Human Papillomavirus Type 6 1.1-30 mcg protein Human Papillomavirus Type 11 1.1 protein-40 mcg
Human Papillomavirus Type 16 1.1 protein-60 mcg Human Papillomavirus Type 18 1.1 protein-40 mcg
Human Papillomavirus Type 31 1.1 protein-20 mcg
Human Papillomavirus Type 33 1.1 protein -20 mcg
Human Papillomavirus Type 45 1.1 protein -20 mcg
Human Papillomavirus Type 52 1.1 protein-20 mcg Human Papillomavirus Type 58 1.1 protein-20 mcg
Adsorbed on amorphous aluminum hydroxyphosphate sulphate adjuvant (500 mcg Al)
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Single dose. 0.5 mL in 3 mL Ph. Eur./USP Type I glass vial with Fluro TecTM-laminated stopper and aluminum seal with brown plastic flip-off cap [Box of 10's)
|
| Pharmacologic Category |
-
|
| Manufacturer |
Merck Sharp & Dohme Corporation
|
| Country of Origin |
United States of America
|
| Trader |
N/A
|
| Importer |
Merck Sharp & Dohme (1.A.) LLC
|
| Distributor |
N/A
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
05 August 2022
|
| Expiry Date |
04 April 2027
|