Zostavax | European Medicines Agency (EMA)

June 11, 2025

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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.

English (EN)
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First published: 17/01/2007Last updated: 11/06/2025

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Product information

English (EN)
(1.9 MB – PDF)

First published: 14/12/2009Last updated: 11/06/2025

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Latest procedure affecting product information:
IA/0142/G

30/06/2022

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).

English (EN)
(135.28 KB – PDF)

First published: 17/01/2007Last updated: 11/06/2025

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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 vaccines

Therapeutic 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.

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Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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