Sortis

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.