Crestor and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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.


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.

Key facts

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

Status
European Commission final decision
Opinion date
30/06/2014

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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