Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ZOSTAVAX powder and solvent for suspension for injection.
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe.
shingles (herpes zoster) vaccine (live)
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection. The powder is a white to off-white compact crystalline plug. The solvent is a clear, colourless fluid. |
After reconstitution, 1 dose (0.65 mL) contains: Varicella-zoster virus1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU2.
1 produced in human diploid (MRC-5) cells
2 PFU = Plaque-forming units
This vaccine may contain traces of neomycin. See sections 4.3 and 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Attenuated varicella-zoster virus |
Varicella-zoster virus vaccine was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications. |
| List of Excipients |
|---|
|
Powder: Sucrose Solvent: Water for injections |
ZOSTAVAX with solvent for reconstitution supplied in a vial: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
ZOSTAVAX with solvent for reconstitution supplied in a pre-filled syringe: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) without needle in pack size of 1, 10 or 20.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/06/341/001
EU/1/06/341/002
EU/1/06/341/005
EU/1/06/341/006
EU/1/06/341/007
EU/1/06/341/008
EU/1/06/341/009
EU/1/06/341/010
EU/1/06/341/011
EU/1/06/341/012
EU/1/06/341/013
Date of first authorisation: 19 May 2006
Date of latest renewal: 11 February 2016
| Drug | Countries | |
|---|---|---|
| ZOSTAVAX | Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa |
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