Shingrix
herpes zoster vaccine (recombinant, adjuvanted)
Table of contents
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.
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List item
Shingrix : EPAR - Medicine overview (PDF/116.03 KB)
First published: 28/03/2018
Last updated: 28/09/2020
EMA/422738/2020 -
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List item
Shingrix : EPAR - Risk-management-plan summary (PDF/377.94 KB)
First published: 28/09/2020
Last updated: 13/10/2021
Authorisation details
Product details | |
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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 | |
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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 - R/0057
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.