Shingrix Powder and Suspension for Suspension for Injection (IM)

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

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Active ingredient:

Herpes Zoster Vaccine (recombinant, adjuvanted)

Available from:

N/A; Importer: GlaxoSmithKline Philippines, Inc.; Distributor: GlaxoSmithKline Philippines, Inc.

INN (International Name):

Herpes Zoster Vaccine (recombinant, adjuvanted)

Dosage:

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

Pharmaceutical form:

Powder and Suspension for Suspension for Injection (IM)

Units in package:

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), 3 mL Type I colorless glass vial with bromobutyl rubber stopper and brown flip-off cap (lyophilized vaccine) + 0.5 mL in 3 mL Ty

Manufactured by:

GlaxoSmithKline Biologicals S.A., Belgium

Product summary:

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

Authorization date:

2023-05-02