Zostavax

RSS

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 18/01/2018

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
zoster vaccine (live)
Therapeutic area (MeSH)
  • Herpes Zoster
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BK02
Publication details
Marketing-authorisation holder
MSD VACCINS
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
18/05/2006
Contact address
162 avenue Jean Jaurès
69007 Lyon
France

Product information

14/01/2018 Zostavax - EMEA/H/C/000674 - II/0115

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Viral vaccine

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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