Crestor 5 mg - referral

Current status

European Commission final decision

Overview

Crestor (rosuvastatin calcium) is a selective 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) that has been approved for use as a lipid-regulating agent in the management of patients with dyslipidaemia.

A Marketing Authorisation for Crestor (10 to 40 mg) was originally granted to AstraZeneca in The Netherlands on 6 November 2002 and a Mutual Recognition Procedure was started on 7 December 2002. The application was withdrawn in Germany, Norway and Spain, but the procedure was positively ended in all other Member States on 7 March 2003. As part of the marketing authorisation for rosuvastatin within Europe, AstraZeneca committed to apply for a 5-mg dose of rosuvastatin together with any necessary variations within 12 months of completion of the Mutual Recognition Process for the 10 mg, 20 mg and 40 mg formulations.

On the basis of the marketing authorisation for Crestor (5 mg) granted by The Netherlands, on 21 July 2004 the applicant submitted an application for Mutual Recognition to 13 Concerned Member States. This procedure started on 04 August 2004. The approved use in The Netherlands was a 5 mg start dose for patients with predisposing factors to myopathy, and 10 mg as the recommended start dose for patients without these predisposing factors. The main issue during the procedure was whether the 5 mg strength should be the recommended start dose for all patients. The issue was referred for arbitration by the UK on 1 November 2004 (day 89).

The arbitration procedure started on 18 November 2004. The Rapporteur and Co-Rapporteur appointed were Dr P. Nilsson and Dr. G. Calvo, respectively. Written explanations were provided by the Marketing Authorisation Holder on 07 February 2005.

During its April 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Crestor 5 mg or Crestor 10 mg as start dose. The choice of start dose in the individual patient should take into account aspects of efficacy and safety, as detailed in the SPC. Changes to SPC section 4.2 (Posology and method of administration) and 4.4 (Special warnings and special precautions for use) arising from the arbitration process were agreed by CHMP and a positive opinion was adopted on 21 April 2005.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 09 August 2005.

Opinion following an Article 29(2) referral for Crestor 5 mg International Non-Proprietary Name (INN): Rosuvastatin calcium: Background information

AdoptedReference Number: EMEA/CHMP/145829/2005

Key facts

About this medicine

• Approved name:
  Crestor 5 mg
• International non-proprietary name (INN) or common name:
  rosuvastatin calcium

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/145829/05
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  21/04/2005
• EC decision date:
  09/08/2005

All documents

Crestor 5 mg - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(2) referral for Crestor 5 mg International Non-Proprietary Name (INN): Rosuvastatin calcium: Background information

AdoptedReference Number: EMEA/CHMP/145829/2005

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.