Furosemide Vitabalans - referral

Current status

European Commission final decision

Overview

On 18 October 2012, 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 Furosemide Vitabalans. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Furosemide Vitabalans do not outweigh its risks, and the marketing authorisation cannot be granted in Estonia and in the following Member States of the EU: the Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Poland, Slovakia, Slovenia and Sweden, as well as Norway.

After re-examination, the Committee confirmed these recommendations on 18 February 2013.

What is Furosemide Vitabalans?

Furosemide Vitabalans is a medicine that contains the active substance furosemide. It was to be available as tablets (40 mg). The active substance in Furosemide Vitabalans, furosemide, belongs to a group of medicines known as diuretics. It works in the kidneys by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.

Furosemide Vitabalans was intended to be used to treat the following conditions:

• oedema (swelling) associated with congestive heart failure (a type of heart disease);
• cirrhosis of the liver (a type of liver disease) and renal disease, including nephrotic syndrome;
• mild to moderate hypertension (high blood pressure).

Why was Furosemide Vitabalans reviewed?

Vitabalans Oy submitted an application for Furosemide Vitabalans to the Estonian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Estonia) 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 the Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Slovakia, Slovenia and Sweden).

However, the Member States were not able to reach an agreement and the Polish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.

The Polish and Lithuanian agencies were of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Furosemide Vitabalans. The application was supported by published literature rather than studies carried out with Furosemide Vitabalans, because furosemide has a history of well-established use in the EU for at least 10 years. The grounds for the referral were that the data from the literature submitted to support this application could not be applied to Furosemide Vitabalans and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of Furosemide Vitabalans.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted were not sufficient to show that Furosemide Vitabalans could be used safely and effectively based on the well established use of furosemide. The CHMP concluded that the balance of the benefits and risks of Furosemide Vitabalans could not be established, and therefore the marketing authorisation for Furosemide Vitabalans should not be granted in all concerned Member States.

The CHMP confirmed the above conclusions after re-examining its opinion.

The European Commission issued a decision on 14 May 2013.

Questions and answers on the referral for Furosemide Vitabalans (tablet, 40 mg)

Reference Number: EMA/107842/2013 Rev. 1 Summary:

On 18 October 2012, 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 Furosemide Vitabalans.

Key facts

About this medicine

• Approved name:
  Furosemide Vitabalans
• International non-proprietary name (INN) or common name:
  furosemide

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1334
• 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:
  18/02/2013
• EC decision date:
  14/05/2013

All documents

Opinion provided by Committee for Medicinal Products for human Use

Questions and answers on the referral for Furosemide Vitabalans (tablet, 40 mg)

Reference Number: EMA/107842/2013 Rev. 1 Summary:

On 18 October 2012, 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 Furosemide Vitabalans.

European Commission final decision

Furosemide Vitabalans Article-29(4) referral - Assessment report

Adopted Reference Number: EMA/254361/2013

Furosemide Vitabalans Article-29(4) referral - Annex I

Furosemide Vitabalans Article-29(4) - Annex II

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.