Shingrix

RSS

herpes zoster vaccine (recombinant, adjuvanted)

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

Overview

An overview of Shingrix and why it is authorised in the EU

Shingrix is a vaccine used to protect adults aged 50 years and over against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles).

Shingles is a painful, blistering rash caused by the reactivation of the virus that causes chickenpox. After a patient has had chickenpox, the virus can lie dormant in the nerves and become active again if the immune system (the body’s natural defences) weakens due, for example, to ageing or to an illness.

This EPAR was last updated on 28/03/2018

Authorisation details

Product details
Name
Shingrix
Agency product number
EMEA/H/C/004336
Active substance
Varicella Zoster Virus glycoprotein E antigen
International non-proprietary name (INN) or common name
herpes zoster vaccine (recombinant, adjuvanted)
Therapeutic area (MeSH)
Herpes Zoster
Anatomical therapeutic chemical (ATC) code
J07BK03
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
GlaxoSmithkline Biologicals SA
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
21/03/2018
Contact address
Rue de l'Institut 89
1330 Rixensart
Belgium

Product information

21/03/2018 Shingrix - EMEA/H/C/004336 -

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

VACCINES

Therapeutic indication

Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older.
The use of Shingrix should be in accordance with official recommendations.

Assessment history

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