Human medicines European public assessment report (EPAR): Shingrix, herpes zoster vaccine (recombinant, adjuvanted), Date of authorisation: 21/03/2018, Revision: 16, Status: Authorised

Shingrix RSS Authorised This medicine is authorised for use in the European Union herpes zoster vaccine (recombinant, adjuvanted) Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision 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. Expand section Collapse section 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. People whose immune system does not work properly and who would benefit from a shorter vaccination schedule can have the second dose one to two 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 and have already developed antibodies against the virus. Shingrix contains small amounts of a surface antigen (protein 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 in two main studies to be effective at preventing shingles and post-herpetic neuralgia in patients 50 years and older. In the first study, 7,695 received Shingrix and 7,710 received placebo (a dummy treatment). 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. Shingrix was also effective in two studies in adults aged 18 years and above at increased risk of developing herpes zoster. In the first study, involving people who had received an autologous (from the patient’s own body) stem cell transplant, the number of people who had herpes zoster was 49 (out of 870) in the Shingrix group compared with 135 (out of 851) in the placebo group; in the second study, involving patients with blood cancer, these figures were 2 (out of 259 people) and 14 (out of 256), respectively. These studies indicate that Shingrix prevented 68% and 87% of cases, respectively. 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 in adults older than 50 years for at least 4 years after vaccination. The vaccine is also effective at protecting adults older than 18 years who are at increased risk of herpes zoster. 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. Shingrix : EPAR - Medicine overview Reference Number: EMA/422738/2020 English (EN) (116.03 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View Other languages (22) български (BG) (139.86 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View español (ES) (116.02 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View čeština (CS) (138.71 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View dansk (DA) (114.85 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View Deutsch (DE) (119.49 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View eesti keel (ET) (112.23 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View ελληνικά (EL) (137.45 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View français (FR) (116.18 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View hrvatski (HR) (139.92 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View italiano (IT) (115.62 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View latviešu valoda (LV) (155.49 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View lietuvių kalba (LT) (138.39 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View magyar (HU) (139.48 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View Malti (MT) (147.6 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View Nederlands (NL) (115.07 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View polski (PL) (141.05 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View português (PT) (116.32 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View română (RO) (137.35 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View slovenčina (SK) (139.1 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View slovenščina (SL) (137.06 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View Suomi (FI) (114.2 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View svenska (SV) (114.93 KB - PDF) First published: 28/03/2018 Last updated: 28/09/2020 View Shingrix : EPAR - Risk management plan English (EN) (6.37 MB - PDF) First published: 28/09/2020 Last updated: 19/12/2025 View Product information Shingrix : EPAR - Product Information English (EN) (971.91 KB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View Other languages (24) български (BG) (1.37 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View español (ES) (1.01 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View čeština (CS) (1.18 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View dansk (DA) (1.08 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View Deutsch (DE) (1.08 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View eesti keel (ET) (999 KB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View ελληνικά (EL) (1.26 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View français (FR) (1.02 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View hrvatski (HR) (1.1 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View íslenska (IS) (1.11 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View italiano (IT) (1.03 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View latviešu valoda (LV) (1.11 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View lietuvių kalba (LT) (1.12 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View magyar (HU) (1.15 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View Malti (MT) (1.25 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View Nederlands (NL) (1.03 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View norsk (NO) (997.75 KB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View polski (PL) (1008.05 KB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View português (PT) (1.08 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View română (RO) (1.12 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View slovenčina (SK) (1.14 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View slovenščina (SL) (1.08 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View Suomi (FI) (1.06 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View svenska (SV) (1.06 MB - PDF) First published: 28/03/2018 Last updated: 23/03/2026 View Latest procedure affecting product information: VR/0000315862 12/02/2026 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). Shingrix : EPAR - All Authorised presentations English (EN) (80.18 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View Other languages (24) български (BG) (98.58 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View español (ES) (85.24 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View čeština (CS) (131.21 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View dansk (DA) (89.85 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View Deutsch (DE) (81.64 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View eesti keel (ET) (79.55 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View ελληνικά (EL) (105.14 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View français (FR) (80.05 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View hrvatski (HR) (103.49 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View íslenska (IS) (79.87 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View italiano (IT) (81.02 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View latviešu valoda (LV) (101.92 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View lietuvių kalba (LT) (106.87 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View magyar (HU) (102.33 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View Malti (MT) (107.1 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View Nederlands (NL) (79.99 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View norsk (NO) (81.6 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View polski (PL) (86.06 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View português (PT) (81.09 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View română (RO) (103.17 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View slovenčina (SK) (73.7 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View slovenščina (SL) (79.33 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View Suomi (FI) (80.32 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View svenska (SV) (60.28 KB - PDF) First published: 28/03/2018 Last updated: 19/12/2025 View Product details Name of medicine Shingrix 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 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. Authorisation details EMA product number EMEA/H/C/004336 Marketing authorisation holder GlaxoSmithKline Biologicals S.A. Rue de l'Institut, 89 B-1330 Rixensart Belgium Marketing authorisation issued 21/03/2018 Revision 16 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Shingrix : EPAR - Procedural steps taken and scientific information after the authorisation English (EN) (179.71 KB - PDF) First published: 17/07/2025 Last updated: 23/03/2026 View Shingrix : EPAR - Procedural steps taken and scientific information after the authorisation (archive) English (EN) (293.32 KB - PDF) First published: 22/08/2019 Last updated: 17/07/2025 View Shingrix-X-0000243671 : EPAR - Assessment report - Extension Adopted Reference Number: EMADOC-1700519818-2471078 English (EN) (570.04 KB - PDF) First published: 19/12/2025 View Shingrix-H-C-4336-II-0022 : EPAR - Assessment report - Variation Adopted Reference Number: EMA/447929/2020 English (EN) (7.65 MB - PDF) First published: 28/09/2020 View CHMP post-authorisation summary of positive opinion for Shingrix (II-22) Adopted Reference Number: EMA/CHMP/383838/2020 English (EN) (136.82 KB - PDF) First published: 24/07/2020 View Initial marketing authorisation documents Shingrix : EPAR - Public assessment report Adopted Reference Number: EMA/88588/2018 English (EN) (3.69 MB - PDF) First published: 28/03/2018 Last updated: 28/03/2018 View CHMP summary of positive opinion for Shingrix Adopted Reference Number: EMA/CHMP/811150/2017 English (EN) (69.26 KB - PDF) First published: 26/01/2018 Last updated: 26/01/2018 View News on Shingrix Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020 24/07/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018 26/01/2018 More information on Shingrix EMEA-001426-PIP01-13-M03 - paediatric investigation plan Safety and effectiveness of RZV in adults ≥18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104) - post-authorisation study Non-interventional (observational) post-licensure study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged =18 years with psoriasis or psoriatic arthritis (EPI-ZOSTER-045 VE US 216976) - post-authorisation study 209452 - A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 years of age in the United States - post-authorisation study A retrospective matched cohort study on the association between herpes zoster vaccination and dementia and mild cognitive impairment using electronic health records (ZOSTER-122 AIML 222419) - post-authorisation study 213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in the rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) patient populations in adults 18 years of age and older (EPI-ZOSTER-044 VE US) - post-authorisation study 209696 - A targeted safety study, EPI-ZOSTER-032 VS US DB, to evaluate the safety of Shingrix in adults ≥ 65 years of age in the United States. - post-authorisation study Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age (EPI-ZOSTER-039 VS US DB 214420) - post-authorisation study 209570 - Long-Term Effectiveness Study of Shingrix in Adults ≥ 50 Years of Age in the US (EPI-ZOSTER-031 VE US) - post-authorisation study 219111- A retrospective matched cohort database study in the United States to evaluate the effectiveness of recombinant zoster vaccine (RZV) in patients with autoimmune diseases (AIDs) (EPI-ZOSTER-097 VE US DB) - post-authorisation study 212853 - Shingrix for intramuscular injection Drug Use Investigation - post-authorisation study Topics Medicines Vaccines This page was last updated on 23/03/2026 Share this page