- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 June 2025, the European Commission withdrew the marketing authorisation for Zostavax (shingles (herpes zoster) vaccine (live)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Zostavax was granted marketing authorisation in the EU on 19 May 2006 for the prevention of herpes zoster and herpes zoster-related post-herpetic neuralgia in people 50 years of age or older. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2010. It was then granted unlimited validity in 2015. The product had not been marketed in the EU since 1 May 2025.
Zostavax : EPAR - Summary for the public
English (EN) (177.53 KB - PDF)
български (BG) (230.81 KB - PDF)
español (ES) (168.21 KB - PDF)
čeština (CS) (205.91 KB - PDF)
dansk (DA) (164.43 KB - PDF)
Deutsch (DE) (174.13 KB - PDF)
eesti keel (ET) (156.09 KB - PDF)
ελληνικά (EL) (243.93 KB - PDF)
français (FR) (169.59 KB - PDF)
hrvatski (HR) (196.63 KB - PDF)
italiano (IT) (166.28 KB - PDF)
latviešu valoda (LV) (208.31 KB - PDF)
lietuvių kalba (LT) (209.21 KB - PDF)
magyar (HU) (195.85 KB - PDF)
Malti (MT) (223.68 KB - PDF)
Nederlands (NL) (171.11 KB - PDF)
polski (PL) (208.34 KB - PDF)
português (PT) (167.87 KB - PDF)
română (RO) (211.94 KB - PDF)
slovenčina (SK) (212.56 KB - PDF)
slovenščina (SL) (195.85 KB - PDF)
Suomi (FI) (158.04 KB - PDF)
svenska (SV) (176.01 KB - PDF)
Product information
Zostavax : EPAR - Product Information
English (EN) (1.9 MB - PDF)
български (BG) (2.44 MB - PDF)
español (ES) (1.94 MB - PDF)
čeština (CS) (2.31 MB - PDF)
dansk (DA) (1.94 MB - PDF)
Deutsch (DE) (2.18 MB - PDF)
eesti keel (ET) (1.83 MB - PDF)
ελληνικά (EL) (2.54 MB - PDF)
français (FR) (1.95 MB - PDF)
hrvatski (HR) (2.14 MB - PDF)
íslenska (IS) (1.81 MB - PDF)
italiano (IT) (2.13 MB - PDF)
latviešu valoda (LV) (2.16 MB - PDF)
lietuvių kalba (LT) (2.2 MB - PDF)
magyar (HU) (2.22 MB - PDF)
Malti (MT) (2.98 MB - PDF)
Nederlands (NL) (2.13 MB - PDF)
norsk (NO) (1.85 MB - PDF)
polski (PL) (2.49 MB - PDF)
português (PT) (2.04 MB - PDF)
română (RO) (2.35 MB - PDF)
slovenčina (SK) (2.29 MB - PDF)
slovenščina (SL) (2.08 MB - PDF)
Suomi (FI) (2.1 MB - PDF)
svenska (SV) (1.81 MB - PDF)
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).
Zostavax : EPAR - All Authorised presentations
English (EN) (135.28 KB - PDF)
български (BG) (169.85 KB - PDF)
español (ES) (118.29 KB - PDF)
čeština (CS) (131.37 KB - PDF)
dansk (DA) (100.48 KB - PDF)
Deutsch (DE) (103.05 KB - PDF)
eesti keel (ET) (87.78 KB - PDF)
ελληνικά (EL) (113.21 KB - PDF)
français (FR) (100.71 KB - PDF)
hrvatski (HR) (109.15 KB - PDF)
íslenska (IS) (91.16 KB - PDF)
italiano (IT) (94.31 KB - PDF)
latviešu valoda (LV) (107.69 KB - PDF)
lietuvių kalba (LT) (109.5 KB - PDF)
magyar (HU) (116.94 KB - PDF)
Malti (MT) (155.65 KB - PDF)
Nederlands (NL) (151.94 KB - PDF)
norsk (NO) (103.92 KB - PDF)
polski (PL) (116.05 KB - PDF)
português (PT) (103.25 KB - PDF)
română (RO) (116.67 KB - PDF)
slovenčina (SK) (163.78 KB - PDF)
slovenščina (SL) (121.43 KB - PDF)
Suomi (FI) (133.58 KB - PDF)
svenska (SV) (101.75 KB - PDF)
Product details
- Name of medicine
- Zostavax
- Active substance
- varicella-zoster virus (live, attenuated)
- International non-proprietary name (INN) or common name
- shingles (herpes zoster) vaccine (live)
- Therapeutic area (MeSH)
- Herpes Zoster
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07BK02
Pharmacotherapeutic group
Viral vaccinesTherapeutic indication
Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia.
Zostavax is indicated for immunisation of individuals 50 years of age or older.
Authorisation details
- EMA product number
- EMEA/H/C/000674
- Marketing authorisation holder
- Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands - Opinion adopted
- 23/03/2006
- Marketing authorisation issued
- 19/05/2006
- Withdrawal of marketing authorisation
- 01/06/2025
- Revision
- 33
Assessment history
Zostavax : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (1.74 MB - PDF)
Zostavax-H-C-674-A20-0052 : EPAR - Assessment Report - Article 20
English (EN) (337.63 KB - PDF)
Zostavax-H-C-674-II-0003 : EPAR - Scientific Discussion - Variation
English (EN) (463.11 KB - PDF)
News on Zostavax
More information on Zostavax
Zostavax: Product information as approved by the CHMP on 13 December 2012, pending endorsement by the European Commission
English (EN) (1.47 MB - PDF)