Crestor and associated names - referral

Current status

European Commission final decision

Overview

On 25 April 2014, the European Medicines Agency recommended a change to the marketing authorisations of the cholesterol-lowering medicine Crestor to allow its use in children aged between 6 to 10 years.

Crestor and associated names are used to treat blood fat disorders (primary hypercholesterolaemia and mixed dyslipidaemia) and to prevent cardiovascular events, such as heart attacks. They were previously only authorised in EU Member States for adults and children above the age of 10 years.

A review by the Agency's Committee for Medicinal Products for Human Use (CHMP) has now concluded that the benefits of Crestor in treating blood fat disorders also outweigh its risk in children aged 6 to 10 years. Results of studies in this age group showed that the medicine led to long-term significant reductions in blood levels of low-density lipoprotein cholesterol, LDL-C ('bad cholesterol') and that the medicine was generally well tolerated.

The review was carried out according to the terms of the EU's paediatric regulation, under which medicines authorised by national procedures in the EU can be evaluated centrally by the European Medicines Agency for uses concerning children.

The Agency's recommendation has been sent to the European Commission which endorsed it and issued a legally binding decision valid throughout the EU on 30 June 2014.

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More about the medicine

Crestor (rosuvastatin) belongs to a group of cholesterol-lowering medicines known as statins, which work by inhibiting the action of HMG-CoA reductase, an enzyme involved in the production of cholesterol in the liver.

Crestor was first authorised in the EU in the Netherlands in November 2002. At the time of this review, Crestor and associated names were authorised in all EU Member States as well as in Iceland and Norway.

Crestor - Article 29 paediatrics referral - Assessment report

Key facts

About this medicine

• Approved name:
  Crestor and associated names
• International non-proprietary name (INN) or common name:
  rosuvastatin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29-PAE/1378
• Type:
  Article 29 paediatrics

  This type of procedure may be triggered by a marketing-authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in children for a product authorised under Directive 2001/83/EC.

Key dates and outcomes

• CHMP opinion date:
  30/06/2014

All documents

European Commission final decision

Crestor - Article 29 paediatrics referral - Annex I

Crestor - Article 29 paediatrics referral - Annex II

Crestor - Article 29 paediatrics referral - Annex III

Crestor - Article 29 paediatrics referral - Assessment report

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.