Sortis

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Atorvastatin calcium is a synthetic 3 hydroxy-3 methylglutaryl-coenzyme A reductase (HMG-CoA reductase) inhibitor. This enzyme is involved in cholesterol biosynthesis by catalyzing the conversion reaction of HMG-CoA to mevalonic acid. The function of lowering the amount of cholesterol leads to the result in clearing the low-density lipoprotein (LDP) receptor upregulation, and increased hepatic clearance of plasma LDL. The calcium salt of atorvastatin is used in the treatment of primary hypercholesterolemia and dyslipidemia.

Sortis and associated names 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets contain atorvastatin calcium as active substance. These medicinal products have been approved via national and/or mutual recognition procedures across EU. In the mutual recognition procedure Germany acted as Reference Member State.

The present application was submitted under Article 29 of Regulation (EC) No 1901/2006, as amended, to obtain approval for a new pharmaceutical form (chewable tablets) intended to be used as a suitable alternative for paediatric patients, including a lower strength dose (5mg). Parallel applications have been submitted under Article 29 of Regulation (EC) No 1901/2006 as amended, to obtain approval for higher strengths of the same pharmaceutical form (chewable tablets), as well as to extend the indication of the existing film-coated tablets to include treatment of hypercholesterolemia in paediatric patients aged 10 years or older and to update the product information to provide information for use of atorvastatin in the paediatric population.

Key facts

Approved name
Sortis
International non-proprietary name (INN) or common name
atorvastatin
Associated names
  • Lipitor
  • Zarator
  • Orbeos
  • Tahor
  • Liprimar
  • Atorvastatin
  • Atorvastatina
  • Edovin
  • Obradon
  • Xarator
  • Torvast
  • Totalip
  • Texzor
  • Cardyl
  • Prevencor
Reference number
EMEA/H/A-29 PAD/1254
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
18/03/2010
EC decision date
01/07/2010

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