Priorix - referral

Current status

European Commission final decision

Overview

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.

Questions and answers on Priorix (measles, mumps and rubella vaccine (live))

Adopted Reference Number: EMA/CHMP/178705/2012 Summary:

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).

Key facts

About this medicine

• Approved name:
  Priorix
• International non-proprietary name (INN) or common name:
  measles, mumps and rubella vaccine (live)

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1283
• 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.

Key dates and outcomes

• CHMP opinion date:
  15/03/2012
• EC decision date:
  25/05/2012

All documents

Priorix - Article 30 referral - Annex I

Priorix - Article 30 referral - Annex II

Priorix - Article 30 referral - Assessment report

Adopted Reference Number: EMA/360443/2012

Priorix - Article 30 referral - Annex III

Adopted

Questions and answers on Priorix (measles, mumps and rubella vaccine (live))

Adopted Reference Number: EMA/CHMP/178705/2012 Summary:

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).

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.