Zostavax
shingles (herpes zoster) vaccine (live)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Zostavax. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zostavax.
Authorisation details
Product details | |
---|---|
Name |
Zostavax
|
Agency product number |
EMEA/H/C/000674
|
Active substance |
varicella-zoster virus (live, attenuated)
|
International non-proprietary name (INN) or common name |
shingles (herpes zoster) vaccine (live)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07BK02
|
Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
33
|
Date of issue of marketing authorisation valid throughout the European Union |
19/05/2006
|
Contact address |
Waarderweg 39 |
Product information
30/06/2022 Zostavax - EMEA/H/C/000674 - IA/0142/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.