SHINGRIX Powder for suspension for injection Ref.[27522] Active ingredients: Human varicela zoster immunoglobulin

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: GlaxoSmithKline Biologicals S.A., Rue de lInstitut 89, B-1330 Rixensart, Belgium

Product name and form

Shingrix powder and suspension for suspension for injection.

Herpes zoster vaccine (recombinant, adjuvanted).

Pharmaceutical Form

Powder and suspension for suspension for injection.

The powder is white.

The suspension is an opalescent, colourless to pale brownish liquid.

Qualitative and quantitative composition

After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus1 glycoprotein E antigen2,3 50 micrograms.

1 Varicella Zoster Virus = VZV

2 adjuvanted with AS01B containing:

plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms
3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms

3 glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology

For the full list of excipients, see section 6.1.

Active Ingredient Description
Human varicela zoster immunoglobulin

Human varicella zoster immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against varicella-zoster virus. It is used for prophylaxis against varicella zoster virus (VZV) infection.
List of Excipients

Powder (gE antigen):

Sucrose
Polysorbate 80 (E433)
Sodium dihydrogen phosphate dihydrate (E339)
Dipotassium phosphate (E340)

Suspension (AS01B Adjuvant System):

Dioleoyl phosphatidylcholine (E322)
Cholesterol
Sodium chloride
Disodium phosphate anhydrous (E339)
Potassium dihydrogen phosphate (E340)
Water for injections

For adjuvant see also section 2.

Pack sizes and marketing

  • Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
  • Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).

Shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Biologicals S.A., Rue de l’Institut 89, B-1330 Rixensart, Belgium

Marketing authorization dates and numbers

EU/1/18/1272/001
EU/1/18/1272/002

Date of first authorisation: 21 March 2018

Drugs

Drug Countries
SHINGRIX Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland
 
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