Pravachol - referral

Current status

European Commission final decision

Overview

Pravastatin is a hydrophilic inhibitor of the hydroxy-methyl-glutaryl conenzyme A reductase (HMGCoA reductase). This enzyme catalyses the initial rate-limiting step in cholesterol biosynthesis (the reduction of 3-hydroxy-3-methyl-glutaryl-Coenzyme A into mevalonic acid). Pravastatin is a serum lipid-lowering agent.

Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States. On 8 November 2002, the European Commission presented to the EMEA (see Annex 1) a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product Pravachol and associated names.

The referral procedure started on 21 November 2002. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of pravastatin is considered to be favourable in the following indications:

Hypercholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.

Primary prevention

Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia and at high risk of a first cardiovascular event, as an adjunct to diet (see section 5.1).

Secondary prevention

Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors (see section 5.1).

Post transplantation

Reduction of post transplantation hyperlipidaemia in patients receiving immunossupressive therapy following solid organ transplantation. (see sections 4.2, 4.5 and 5.1).

The CPMP gave a positive opinion on 20 November 2003 recommending the harmonisation of the SPC for Pravachol and associated names.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.

A Decision was issued by the European Commission on 2 March 2004.

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Pravachol and associated names (See Annex I) International Non-Proprietary Name (INN): Pravastatin: Background informatio...

Adopted Reference Number: EMEA/CPMP/6214/03/Final

Key facts

About this medicine

• Approved name:
  Pravachol
• International non-proprietary name (INN) or common name:
  pravastatin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/6214/03
• 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:
  21/11/2003
• EC decision date:
  02/03/2004

All documents

Pravachol - Article 30 referral - Annex I, II, III

Adopted

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Pravachol and associated names (See Annex I) International Non-Proprietary Name (INN): Pravastatin: Background informatio...

Adopted Reference Number: EMEA/CPMP/6214/03/Final

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.