Zostavax

Withdrawn

This medicine's authorisation has been withdrawn

shingles (herpes zoster) vaccine (live)

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

Product information

Zostavax : EPAR - Product Information

Zostavax : EPAR - All Authorised presentations

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.

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

Changes since initial authorisation of medicine

Zostavax : EPAR - Procedural steps taken and scientific information after authorisation

Zostavax-H-C-674-A20-0052 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/78658/2013

Zostavax-H-C-674-II-0003 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Zostavax : EPAR - Scientific Discussion

Zostavax : EPAR - Procedural steps taken before authorisation