Shingrix

herpes zoster vaccine (recombinant, adjuvanted)

  • Email
  • Help

About

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.

How is Shingrix used?

Shingrix can only be obtained with a prescription and should be used according to official recommendations. It is available as a powder and a suspension to be mixed together by a doctor or a nurse before being injected into the upper arm muscle.

The vaccination course consists of 2 injections given 2 months apart. If necessary, the second dose can be given later but within 6 months after the first dose.

For more information about using Shingrix, see the package leaflet or contact your doctor or pharmacist.

How does Shingrix work?

Shingrix has been designed to prevent shingles in people who have been in contact with the varicella zoster virus (the virus that causes chickenpox) and have already developed antibodies against the virus.

Shingrix contains small amounts of the surface antigens (proteins from the surface) of the virus to stimulate the body to make antibodies against the virus. It also contains an ‘adjuvant’ which is made of substances to help strengthen the immune responses to the vaccine.

Patients given Shingrix will be able to produce antibodies against the virus more quickly when the virus is reactivated and they will therefore have protection against the disease.

What benefits of Shingrix have been shown in studies?

Shingrix has been shown to be effective at preventing shingles and post-herpetic neuralgia.

Shingrix was assessed in two main studies in around 30,000 adults. In both studies, the main measure of effectiveness was the number of people having shingles in the group receiving the vaccine compared with the group receiving placebo (a dummy vaccine). The studies also looked at the number of people who had post-herpetic neuralgia after vaccination.

In the first study with adults aged 50 years and over, 7,695 received Shingrix and 7,710 received placebo. After just over 3 years on average, 6 adults had had shingles in the Shingrix group compared with 210 in the placebo group. After almost 4 years, nobody had had post-herpetic neuralgia in the Shingrix group compared with 18 in the placebo group. This indicates that Shingrix prevented 97% of shingles cases and 100% of cases of post-herpetic neuralgia in this study.

The second study involved adults aged 70 and over who received either Shingrix or placebo. Looking at the results for adults in this age group from both studies together, 25 adults out of 8,250 who received Shingrix had shingles within 4 years after vaccination compared with 284 out of 8,346 who received placebo. After 4 years, 4 adults had had post-herpetic neuralgia in the Shingrix group compared with 36 in the placebo group. This indicates that Shingrix prevented 91% of shingles cases and 89% of cases of post-herpetic neuralgia in adults aged 70 years and older.

Overall, the vaccine effectiveness was similar across ages.

What are the risks associated with Shingrix?

The most common side effects with Shingrix (which may affect more than 1 in 10 people) are reactions at the site of injection (such as pain, redness and swelling), chills, fever, muscle pain, tiredness, headache and side effects of the digestive system such as nausea, vomiting, diarrhoea and stomach pain. Most of these reactions last for 2 to 3 days.

For the full list of side effects and restrictions with Shingrix, see the package leaflet.

Why is Shingrix authorised in the EU?

Shingrix has been shown to be highly effective at preventing shingles and post-herpetic neuralgia across all age groups older than 50 years for at least 4 years after vaccination. Side effects related to the use of Shingrix seemed to be mostly temporary and were manageable with standard care.

The European Medicines Agency therefore decided that Shingrix’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Shingrix?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Shingrix have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Shingrix is continuously monitored. Side effects reported with Shingrix are carefully evaluated and any necessary action taken to protect patients.

Other information about Shingrix

Shingrix received a marketing authorisation valid throughout the EU on 21 March 2018.

Name Language First published Last updated
Shingrix : EPAR - Medicine overview BG = bălgarski 2018-03-28  
Shingrix : EPAR - Medicine overview ES = español 2018-03-28  
Shingrix : EPAR - Medicine overview CS = čeština 2018-03-28  
Shingrix : EPAR - Medicine overview DA = dansk 2018-03-28  
Shingrix : EPAR - Medicine overview DE = Deutsch 2018-03-28  
Shingrix : EPAR - Medicine overview ET = eesti keel 2018-03-28  
Shingrix : EPAR - Medicine overview EL = elliniká 2018-03-28  
Shingrix : EPAR - Medicine overview EN = English 2018-03-28  
Shingrix : EPAR - Medicine overview FR = français 2018-03-28  
Shingrix : EPAR - Medicine overview IT = italiano 2018-03-28  
Shingrix : EPAR - Medicine overview LV = latviešu valoda 2018-03-28  
Shingrix : EPAR - Medicine overview LT = lietuvių kalba 2018-03-28  
Shingrix : EPAR - Medicine overview HU = magyar 2018-03-28  
Shingrix : EPAR - Medicine overview MT = Malti 2018-03-28  
Shingrix : EPAR - Medicine overview NL = Nederlands 2018-03-28  
Shingrix : EPAR - Medicine overview PL = polski 2018-03-28  
Shingrix : EPAR - Medicine overview PT = português 2018-03-28  
Shingrix : EPAR - Medicine overview RO = română 2018-03-28  
Shingrix : EPAR - Medicine overview SK = slovenčina 2018-03-28  
Shingrix : EPAR - Medicine overview SL = slovenščina 2018-03-28  
Shingrix : EPAR - Medicine overview FI = suomi 2018-03-28  
Shingrix : EPAR - Medicine overview SV = svenska 2018-03-28  
Shingrix : EPAR - Medicine overview HR = Hrvatski 2018-03-28  

This EPAR was last updated on 28/03/2018 .

Authorisation details

Product details

Product details for Shingrix
NameShingrix
Agency product numberEMEA/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 Herpes Zoster
Anatomical therapeutic chemical (ATC) code J07BK03
Additional monitoring

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

Publication details

Publication details for Shingrix
Marketing-authorisation holder

GlaxoSmithkline Biologicals SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union21/03/2018

Contact address:

GlaxoSmithkline Biologicals SA
Rue de l'Institut 89
1330 Rixensart
Belgium

Product information

Product information

21/03/2018  Shingrix -EMEA/H/C/004336

Name Language First published Last updated
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  
Shingrix : EPAR - Product Information HR = Hrvatski 2018-03-28  

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.


Name Language First published Last updated
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  
Shingrix : EPAR - All Authorised presentations HR = Hrvatski 2018-03-28  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Shingrix : EPAR - Public assessment report HR = Hrvatski 2018-03-28  
CHMP summary of positive opinion for Shingrix HR = Hrvatski 2018-01-26  

Authorised

This medicine is approved for use in the European Union