Pantoprazole Bluefish - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Bluefish. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Bluefish outweigh its risks, and the marketing authorisation can be granted in Sweden and in the following Member States of the European Union, Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, Spain as well as in Norway.

The review was carried out under an 'Article 29' referral¹.

¹Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health.

What is Pantoprazole Bluefish?

Pantoprazole Bluefish is a medicine used to treat diseases where the stomach produces too much acid.

The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.

The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.

The active substance in Pantoprazole Bluefish, pantoprazole, is a proton pump inhibitor. It works by blocking 'proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach. By blocking the pumps, pantoprazole reduces acid production.

Pantoprazole Bluefish is presented as gastro-resistant tablets. These are tablets that pass through the stomach without being broken down until they reach the intestine. This prevents the active substance from being destroyed by the acid in the stomach.

Pantoprozole Bluefish is a generic medicine based on the reference medicine Pantecta.

Why was Pantoprazole Bluefish reviewed?

Bluefish Pharmaceuticals AB submitted Pantoprazole Bluefish to the Swedish medicines regulatory agency for a decentralised procedure. This is a procedure when one Member State (the 'reference Member State', in this instance Sweden) assesses a medicine with a view of 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, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal and Spain).

However, the member states were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 July 2009.

The grounds for the referral were concerns expressed by the Dutch, German, Irish and Italian medicines regulatory agencies regarding the bioequivalence study comparing Pantoprazole Bluefish and Pantecta. Bioequivalence studies are used to compare how a generic medicine is absorbed by the body in comparison to the reference medicine.

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 Pantoprazole Bluefish had been shown to be bioequivalent to the reference medicine, and therefore the marketing authorisation should be granted in Sweden and all concerned member states.

The European Commission issued a decision on 30 March 2010.

Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets

Adopted Reference Number: EMEA/CHMP/734816/2009 Rev

Key facts

About this medicine

• Approved name:
  Pantoprazole Bluefish
• International non-proprietary name (INN) or common name:
  pantoprazole
• Associated names:
  Pantecta

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1216
• 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:
  19/11/2009
• EC decision date:
  30/03/2010

All documents

Pantoprazole Bluefish - Article 29 referral - Annex I, II, III, IV

Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets

Adopted Reference Number: EMEA/CHMP/734816/2009 Rev

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.