Sortis - referral

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.

Sortis-EMEA/H/A-29 PAD/1254: Article 29 Paediatrics referral - Assessment Report

AdoptedReference Number: EMA/511645/2010

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  18/03/2010
• EC decision date:
  01/07/2010

All documents

Sortis-EMEA/H/A-29 PAD/1254: Article 29 Paediatrics referral - Annex I, II, III

Adopted

Sortis-EMEA/H/A-29 PAD/1254: Article 29 Paediatrics referral - Assessment Report

AdoptedReference Number: EMA/511645/2010

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.