Simvastatin Vale - referral

Current status

European Commission final decision

Overview

On 25 March 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Simvastatin Vale. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.

What is Simvastatin Vale?

Simvastatin Vale is a medicine that contains the active substance simvastatin. It is available as an oral suspension (20 mg / 5 ml and 40 mg / 5 ml).

The active substance in Simvastatin Vale, simvastatin, belongs to a group of medicines called statins, the standard type of medicine used to reduce cholesterol. Simvastatin Vale is used to treat certain forms of hypercholesterolaemia (high blood cholesterol levels) and to reduce the risk of heart disease and death in patients with atherosclerotic cardiovascular disease (where the arteries become narrower due to fatty materials building up on their inside walls) or diabetes.

Simvastatin Vale is a generic medicine based on a 'reference medicine' already authorised in the EU, called Zocor.

Why was Simvastatin Vale reviewed?

Vale Pharmaceuticals Ltd submitted Simvastatin Vale to the United Kingdom's Medicines and Healthcare Products Regulatory Agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the 'concerned Member States', in this instance Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway).

However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 January 2013.

The grounds for the referral were concerns about the data submitted to show that Simvastatin Vale is 'bioequivalent' to the reference medicine, Zocor. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The bioequivalence study submitted in support of the application compared Simvastatin Vale 20 mg / 5 ml with Zocor 20-mg tablets. However, some Member States considered that the higher strength of 40 mg / 5 ml should have been used, in line with the current guideline on the investigation of bioequivalence.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data were not needed because, based on the data submitted, Simvastatin Vale is expected to produce comparable levels of the active substance in the body as the reference medicine at both strengths. The CHMP therefore concluded that the benefits of Simvastatin Vale outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.

The European Commission issued a decision on 27 May 2013.

Questions and answers on Simvastatin Vale and associated names (simvastatin, oral suspension, 20 mg / 5 ml and 40 mg / 5 ml)

Reference Number: EMA/169486/2013 Rev. 1

Key facts

About this medicine

• Approved name:
  Simvastatin Vale
• International non-proprietary name (INN) or common name:
  simvastatin
• Associated names:
  Simvastatin Vale pharmaceuticals
• Class:
  Statin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1358
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  25/03/2013
• EC decision date:
  27/05/2013

All documents

European Commission final decision

Simvastatin Vale Article-29(4) referral - Annex I

Simvastatin Vale Article-29(4) referral - Annex II

Simvastatin Vale Article-29(4) referral - Annex III

Assessment report for Simvastatin Vale and associated names

Reference Number: EMA/264659/2013

Questions and answers on Simvastatin Vale and associated names (simvastatin, oral suspension, 20 mg / 5 ml and 40 mg / 5 ml)

Reference Number: EMA/169486/2013 Rev. 1

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.