Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines

Current status:
European Commission final decision

Overview

On 13 December 2012, the European Medicines Agency completed a review of the use of monovalent and multivalent measles, mumps, rubella and/or varicella vaccines (MMRV) during pregnancy and in patients with immune deficiencies (weakened immune systems).

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that these vaccines should continue to be avoided during pregnancy, but that inadvertent vaccination of pregnant women with measles-, mumps- and/or rubella-containing vaccines should not be a reason for termination of pregnancy.

In addition MMRV should continue to be avoided in patients with the most severely weakened immune systems, but their use could be considered in less severe immune deficiency. The Committee also recommended that some changes be made to the product information to clarify the risks and precautions to be taken.

Key facts

Approved name
Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines
International non-proprietary name (INN) or common name
Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines
Associated names
  • Amunovax
  • Priorix
  • Priorix Tetra
  • Provarivax
  • R.O.R. Vax
  • Rouvax
  • Trivivac
  • Varilrix
  • Varivax
  • and associated names
Class
Vaccines
Reference number
EMEA/H/A-31/1333
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
13/12/2012
EC decision date
27/06/2013

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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