Shingrix

herpes zoster vaccine (recombinant, adjuvanted)

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Shingrix. The marketing authorisation holder for this medicinal product is GlaxoSmithkline Biologicals SA.

The CHMP adopted an extension to the existing indication as follows:1

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(see section 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold, removed text as strikethrough

Key facts

Name
Shingrix
Agency product number
EMEA/H/C/004336
International non-proprietary name (INN) or common name
  • herpes zoster vaccine (recombinant, adjuvanted)
Active substance
  • Varicella Zoster Virus glycoprotein E antigen
Therapeutic area
Herpes Zoster
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
23/07/2020
Company name
GlaxoSmithkline Biologicals SA
Status
Positive
Application type
Post-authorisation

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