Shingrix

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herpes zoster vaccine (recombinant, adjuvanted)

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

Overview

Shingrix is a vaccine used in adults aged 50 years and over to protect against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles). It can also be used from the age of 18 years and over in adults who are at increased risk of herpes zoster.

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.

Shingrix contains a protein (glycoprotein E) from varicella zoster virus, the virus that causes chickenpox.

This EPAR was last updated on 19/12/2022

Authorisation details

Product details
Name
Shingrix
Agency product number
EMEA/H/C/004336
Active substance
Recombinant varicella zoster virus glycoprotein E
International non-proprietary name (INN) or common name
herpes zoster vaccine (recombinant, adjuvanted)
Therapeutic area (MeSH)
Herpes Zoster
Anatomical therapeutic chemical (ATC) code
J07BK03
Publication details
Marketing-authorisation holder
GlaxoSmithkline Biologicals SA
Revision
9
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

20/10/2022 Shingrix - EMEA/H/C/004336 - II/0054

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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

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;
  • adults 18 years of age or older at increased risk of HZ.

The use of Shingrix should be in accordance with official recommendations.

Assessment history

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