Lescol

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

Key facts

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
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.

Status
European Commission final decision
Opinion date
19/11/2009
EC decision date
15/03/2010

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating