Galantamine Stada - 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 (EU) regarding the authorisation of the medicine Galantamine Stada. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: the Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain.

What is Galantamine Stada?

Galantamine Stada is a medicine that contains the active substance galantamine. It is used to treat symptoms of mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.

In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Galantamine works by blocking acetylcholinesterase, an enzyme that breaks down acetylcholine. By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function. This leads to improvement in the patient's symptoms.

Galantamine Stada is a generic medicine based on a 'reference medicine', Reminyl.

Why was Galantamine Stada reviewed?

Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Austria) 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, Estonia, Finland, Ireland, Portugal, Slovakia and Spain).

However, the Member States were not able to reach an agreement and the Czech Republic referred the matter to the CHMP for arbitration on 26 March 2010.

The grounds for the referral were that bioequivalence studies, to show that Galantamine Stada produces the same levels of active substance in the body as Reminil, had not been conclusive.

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 bioequivalence to the reference medicinal product has not been shown. The CHMP therefore concluded that the benefits of Galantamine Stada do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.

Following the CHMP opinion on 23 September 2010, the Agency was informed on 15 October 2010 that the company withdrew the applications for marketing authorisation in all concerned Member States.

The European Commission issued a decision on this referral on 21 February 2011.

Questions and answers on Galantamine Stada and associated names (galantamine 8, 16 and 24 mg prolonged released tablets)

AdoptedReference Number: EMA/594983/2010

Key facts

About this medicine

• Approved name:
  Galantamine Stada
• International non-proprietary name (INN) or common name:
  galantamine
• Associated names:
  • Galantamina
  • Galantamine Tiefenbacher
  • Galantamina Ciclum
  • Galatnax xl
  • Galastad

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/001268
• 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:
  23/09/2010
• EC decision date:
  21/02/2011

All documents

Galantamine Stada - Article 29 referral - Annex I-II

Adopted

Questions and answers on Galantamine Stada and associated names (galantamine 8, 16 and 24 mg prolonged released tablets)

AdoptedReference Number: EMA/594983/2010

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.