Varilrix

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Procedure started

Overview

EMA starts review of Varilrix (live attenuated varicella virus, OKA strain)

EMA has started a review of the vaccine Varilrix, used for protecting individuals against varicella (chickenpox). The active substance in Varilrix is live attenuated varicella virus (OKA strain).

Varilrix has been authorised in the EU via national procedures. This has led to inconsistency across Member States in the way the vaccine can be used, as seen in the differences in the prescribing information [summaries of product characteristics (SmPCs), labelling and package leaflets] in the countries where the vaccine is available.

EMA will consider the available data on Varilrix and will amend the prescribing information to harmonise the way Varilrix is used in the EU.

The amended information for doctors and patients will be available on the EMA website once the review is concluded.

Key facts

Approved name
Varilrix
International non-proprietary name (INN) or common name

live attenuated varicella virus (OKA strain)

Reference number
EMEA/H/A-30/1499
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Status
Procedure started
Opinion date
25/06/2020

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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