| Product Information |
BR-1441_PI_01.pdf
|
| Registration Number |
BR-1441
|
| Generic Name |
Herpes Zoster Vaccine (recombinant, adjuvanted)
|
| Brand Name |
Shingrix
|
| Dosage Strength |
Formulation:
After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus' glycoprotein E antigen23 50 micrograms.
Varicella Zoster Virus = VZV
2adjuvanted with AS01B containing plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms
and
3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 3glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology 50 micrograms
|
| Dosage Form |
Powder and Suspension for Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
3 mL Type I colorless glass vial with bromobutyl rubber stopper and brown flip-off cap (lyophilized vaccine) + 0.5 mL in 3 mL Type I colorless glass vial with chlorobutyl rubber stopper and blue green flip-off cap (adjuvant as suspension)
|
| Pharmacologic Category |
-
|
| Manufacturer |
GlaxoSmithKline Biologicals S.A.
|
| Country of Origin |
Belgium
|
| Trader |
N/A
|
| Importer |
GlaxoSmithKline Philippines, Inc.
|
| Distributor |
GlaxoSmithKline Philippines, Inc.
|
| Application Type |
Monitored Release (MR) (Re-application)
|
| Issuance Date |
02 May 2023
|
| Expiry Date |
02 May 2028
|