Product Details

GARDASIL Suspension for Intramuscular Injection**

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) L1 Protein Vaccine, Recombinant
20 mcg/0.5mL; 40 mcg/0.5mL; 40 mcg/0.5mL; 20 mug/0.5mL
Suspension for injection

ROA

Intramuscular

Applicant Name

MSD IDEA Pharmaceuticals Nigeria Limited

NRN

A6-100120

Status

Active


Composition

Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein. Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate  

ATC Code

J07BM01  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

0.5 mL x 10's (in 1.5 mL Type I pre-filled glass syringe)  

Product Description

Sterile suspension for injection in a pre-filled syringe. Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid

Manufacturer Name

Merck Sharp & Dohme LLC

Manufacturer Country

UNITED STATES OF AMERICA  

Approval Date

2023-07-10  

Expiry Date

2028-07-05