Zostavax

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shingles (herpes zoster) vaccine (live)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Zostavax. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zostavax.

This EPAR was last updated on 01/07/2022

Authorisation details

Product details
Name
Zostavax
Agency product number
EMEA/H/C/000674
Active substance
varicella-zoster virus (live, attenuated)
International non-proprietary name (INN) or common name
shingles (herpes zoster) vaccine (live)
Therapeutic area (MeSH)
  • Herpes Zoster
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BK02
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
19/05/2006
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

30/06/2022 Zostavax - EMEA/H/C/000674 - IA/0142/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Viral vaccines

Therapeutic indication

Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia.

Zostavax is indicated for immunisation of individuals 50 years of age or older.

Assessment history

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