Priorix

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On 15 March 2012, the European Medicines Agency completed a review of Priorix. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Priorix in the European Union (EU).

What is Priorix?

Priorix is a vaccine used to protect against measles, mumps and rubella (German measles). It can be used in adults, adolescents and children from nine months of age.

Priorix contains small amounts of attenuated (weakened) forms of the viruses that cause measles, mumps and rubella. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given Priorix, the immune system recognises the viruses as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these viruses.

Priorix is marketed in all EU Member States as well as in Norway and Iceland. The company that markets the medicine is GlaxoSmithKline (GSK) Biologicals.

Why was Priorix reviewed?

Priorix is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Due to the divergent national positions, on 20 May 2011, GlaxoSmithKline Biologicals referred the matter to the CHMP in order to harmonise the marketing authorisations for Priorix in the EU

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
The areas harmonised include:

4.1 Therapeutic indications

There was some inconsistency between EU countries regarding the approved lower age limit for Priorix, which varied from nine months to 15 months of age. The CHMP recommended that this should be harmonised to nine months of age. However, since a single dose of Priorix produces a lower immune response in children under 12 months old, the CHMP decided to include a reference to the other sections containing specific information on the use of Priorix in children between nine and 12 months old.

4.2 Posology and method of administration

The CHMP recommended arranging this section according to the dosing recommendations for different age groups. For children between nine and 12 months old, the CHMP decided to include a recommendation to give a second dose preferably within three months of the first dose.

4.3 Contra-indications

There was some inconsistency between EU countries regarding the use of Priorix in patients infected with HIV. The CHMP decided to contraindicate the use of Priorix in people with symptomatic, advanced HIV, since these patients have a severely weakened immune system which puts them at risk of serious health problems following vaccination with attenuated measles virus. Priorix is also contraindicated in people with certain other conditions which severely weaken the immune system.

Other changes

The CHMP also harmonised other sections of the SmPC, including sections 4.4 (warnings and precautions for use), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation) and 5.1 (pharmacodynamic properties).

 

The amended information to doctors and patients is available in the 'All documents' tab.

The European Commission issued a decision on 25 May 2012.

Name Language First published Last updated
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) BG = bălgarski 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) ES = español 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) CS = čeština 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) DA = dansk 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) DE = Deutsch 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) ET = eesti keel 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) EL = elliniká 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) EN = English 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) FR = français 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) IT = italiano 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) LV = latviešu valoda 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) LT = lietuvių kalba 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) HU = magyar 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) MT = Malti 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) NL = Nederlands 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) PL = polski 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) PT = português 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) RO = română 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) SK = slovenčina 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) SL = slovenščina 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) FI = suomi 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) SV = svenska 16/03/2012 21/06/2012

Key facts

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

measles, mumps and rubella vaccine (live)

Associated names
Class
Reference numberEMEA/H/A-30/1283
TypeArticle 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 European Union.

StatusEuropean Commission final decision
Opinion date15/03/2012

All documents

Name Language First published Last updated
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) BG = bălgarski 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) ES = español 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) CS = čeština 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) DA = dansk 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) DE = Deutsch 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) ET = eesti keel 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) EL = elliniká 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) EN = English 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) FR = français 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) IT = italiano 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) LV = latviešu valoda 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) LT = lietuvių kalba 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) HU = magyar 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) MT = Malti 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) NL = Nederlands 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) PL = polski 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) PT = português 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) RO = română 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) SK = slovenčina 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) SL = slovenščina 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) FI = suomi 16/03/2012 21/06/2012
Questions and answers on Priorix (measles, mumps and rubella vaccine (live)) SV = svenska 16/03/2012 21/06/2012
Priorix - Article 30 referral - Annex I BG = bălgarski 19/06/2012  
Priorix - Article 30 referral - Annex I ES = español 19/06/2012  
Priorix - Article 30 referral - Annex I CS = čeština 19/06/2012  
Priorix - Article 30 referral - Annex I DA = dansk 19/06/2012  
Priorix - Article 30 referral - Annex I DE = Deutsch 19/06/2012  
Priorix - Article 30 referral - Annex I ET = eesti keel 19/06/2012  
Priorix - Article 30 referral - Annex I EL = elliniká 19/06/2012  
Priorix - Article 30 referral - Annex I EN = English 19/06/2012  
Priorix - Article 30 referral - Annex I FR = français 19/06/2012  
Priorix - Article 30 referral - Annex I IT = italiano 19/06/2012  
Priorix - Article 30 referral - Annex I LV = latviešu valoda 19/06/2012  
Priorix - Article 30 referral - Annex I LT = lietuvių kalba 19/06/2012  
Priorix - Article 30 referral - Annex I HU = magyar 19/06/2012  
Priorix - Article 30 referral - Annex I MT = Malti 19/06/2012  
Priorix - Article 30 referral - Annex I NL = Nederlands 19/06/2012  
Priorix - Article 30 referral - Annex I PL = polski 19/06/2012  
Priorix - Article 30 referral - Annex I PT = português 19/06/2012  
Priorix - Article 30 referral - Annex I RO = română 19/06/2012  
Priorix - Article 30 referral - Annex I SK = slovenčina 19/06/2012  
Priorix - Article 30 referral - Annex I SL = slovenščina 19/06/2012  
Priorix - Article 30 referral - Annex I FI = suomi 19/06/2012  
Priorix - Article 30 referral - Annex I SV = svenska 19/06/2012  
Priorix - Article 30 referral - Annex II BG = bălgarski 19/06/2012  
Priorix - Article 30 referral - Annex II ES = español 19/06/2012  
Priorix - Article 30 referral - Annex II CS = čeština 19/06/2012  
Priorix - Article 30 referral - Annex II DA = dansk 19/06/2012  
Priorix - Article 30 referral - Annex II DE = Deutsch 19/06/2012  
Priorix - Article 30 referral - Annex II ET = eesti keel 19/06/2012  
Priorix - Article 30 referral - Annex II EL = elliniká 19/06/2012  
Priorix - Article 30 referral - Annex II EN = English 19/06/2012  
Priorix - Article 30 referral - Annex II FR = français 19/06/2012  
Priorix - Article 30 referral - Annex II IT = italiano 19/06/2012  
Priorix - Article 30 referral - Annex II LV = latviešu valoda 19/06/2012  
Priorix - Article 30 referral - Annex II LT = lietuvių kalba 19/06/2012  
Priorix - Article 30 referral - Annex II HU = magyar 19/06/2012  
Priorix - Article 30 referral - Annex II MT = Malti 19/06/2012  
Priorix - Article 30 referral - Annex II NL = Nederlands 19/06/2012  
Priorix - Article 30 referral - Annex II PL = polski 19/06/2012  
Priorix - Article 30 referral - Annex II PT = português 19/06/2012  
Priorix - Article 30 referral - Annex II RO = română 19/06/2012  
Priorix - Article 30 referral - Annex II SK = slovenčina 19/06/2012  
Priorix - Article 30 referral - Annex II SL = slovenščina 19/06/2012  
Priorix - Article 30 referral - Annex II FI = suomi 19/06/2012  
Priorix - Article 30 referral - Annex II SV = svenska 19/06/2012  
Priorix - Article 30 referral - Annex III BG = bălgarski 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III ES = español 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III CS = čeština 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III DA = dansk 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III DE = Deutsch 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III ET = eesti keel 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III EL = elliniká 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III EN = English 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III FR = français 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III IT = italiano 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III LV = latviešu valoda 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III LT = lietuvių kalba 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III HU = magyar 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III MT = Malti 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III NL = Nederlands 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III PL = polski 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III PT = português 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III RO = română 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III SK = slovenčina 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III SL = slovenščina 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III FI = suomi 16/03/2012 19/06/2012
Priorix - Article 30 referral - Annex III SV = svenska 16/03/2012 19/06/2012
Priorix - Article 30 referral - Assessment report (English only) 19/06/2012  

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on Priorix