Lescol - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Lescol and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Lescol and associated names in the European Union (EU), as well as Norway and Iceland.

The review was carried out under an 'Article 30' referral.

The European Commission issued a decision on 15 March 2010.

What is Lescol?

Lescol contains the active substance fluvastatin. Fluvastatin belongs to a group of medicines called 'statins', which are cholesterol-lowering agents. It works by blocking the activity of an enzyme called of HMG-CoA reductase. HMG-CoA reductase is responsible for the production of cholesterol. By blocking this enzyme, the amount of cholesterol in the blood is reduced.

Lescol is used to treat dyslipidaemia (abnormal levels of fat in the blood), particularly 'primary hypercholesterolaemia' and 'mixed dyslipidaemia'. Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high. Primary means that the hypercholesterolaemia does not have any identifiable cause. Patients with mixed dyslipidaemia have high blood levels of 'bad' LDL cholesterol and triglycerides (a type of fat), and low levels of 'good' HDL cholesterol.

Lescol is also used to prevent further serious cardiac events (such as a heart attack) in patients after they went through percutaneous coronary intervention (a surgical procedure that is used to unblock narrowed coronary arteries).

Lescol is also available in the EU under other trade names: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon and Vaditon Prolib.

The company that markets these medicines is Novartis.

Why was Lescol reviewed?

Lescol is authorised in the EU via national procedures. This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed. Lescol has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 9 February 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Lescol 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 SPCs, labelling and package leaflets should be harmonised across the EU.
The areas harmonised include:

4.1 Therapeutic indications
The CHMP agreed on two harmonised indications (the diseases for which the medicine may be used):
“Dyslipidaemia
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Secondary prevention in coronary heart disease
Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).”
The Committee noted that the indication “to slow the progression of coronary atherosclerosis in patients with primary hypercholesterolemia, including mild forms, and coronary heart disease”, which was not approved in some Member States, should be removed because the results from the clinical study did not supported this indication.

4.2 Posology and method of administration
The CHMP noted that for the treatment of dyslipidaemia, the main differences in dosing recommendations were related to the starting dose. The Committee concluded that initial dosing ranging from 20 to 80 mg/day is appropriate. For patients with coronary heart disease after percutaneous coronary interventions, the CHMP agreed that the recommended daily dose is 80 mg. The dosage in specific populations, such as children and patients with kidney problems, was also harmonised.

4.3 Contra-indications
The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used):

• in patients with known hypersensitivity to fluvastatin or any of the excipients;
• in patients with active liver disease, or unexplained, persistent elevations in serum transaminases (see sections 4.2, 4.4 and 4.8);
• during pregnancy and lactation (see section 4.6).

The Committee noted that some contra-indications that were included in the SPC in some Member States could be removed. The contra-indications that were removed were: use in children, in patients with myopathic disorders and patient with severe renal impairment, as warnings and cautionary statements are already included in sections 4.2 and 4.4.

Other changes
The CHMP harmonised the SPC section on special warnings and included warnings related to the use of Lescol in children.

The amended information to doctors and patients is available under the "All documents" tabs.

Questions and answers on the referral for Lescol and associated names Capsules containing 20 mg or 40 mg fluvastatin Prolonged-release tablets containing 80 mg fluvastatin

Adopted Reference Number: EMEA/CHMP/736379/2009

Key facts

About this medicine

• Approved name:
  Lescol
• International non-proprietary name (INN) or common name:
  fluvastatin
• Associated names:
  • Canef
  • Cardiol
  • Cardiol XL
  • Cranoc
  • Digardil
  • Digaril Prolib
  • Fluvastatin Novartis
  • Fluvastatina
  • Fractal
  • Leposit Prolib
  • Lescol Depot
  • Lescol Exel
  • Lescol LP
  • Lescol MR
  • Lescol Prolib
  • Lescol XL
  • Lipaxan
  • Lipaxin
  • Liposit
  • Locol
  • Lymetel
  • Primesin
  • Vaditon
  • Vaditon Prolib

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1078
• 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:
  19/11/2009
• EC decision date:
  15/03/2010

All documents

Lescol - Article 30 referrals - Annex I-III

Adopted

Questions and answers on the referral for Lescol and associated names Capsules containing 20 mg or 40 mg fluvastatin Prolonged-release tablets containing 80 mg fluvastatin

Adopted Reference Number: EMEA/CHMP/736379/2009

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.