Tibolona Aristo and Tibocina and associated names - referral

Current status

European Commission final decision

Overview

On 19 December 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 medicines Tibolona Aristo and Tibocina. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks, and the marketing authorisations can be granted in Spain and in the following Member States of the EU: Belgium, Germany and the Netherlands.

What are Tibolona Aristo and Tibocina?

Tibolona Aristo and Tibocina are medicines that contain the active substance tibolone; they are available as tablets (2.5 mg). Tibolone is a type of hormone replacement therapy (HRT) and is used to alleviate the symptoms of the menopause (such as hot flushes) in women who have not had a natural period for at least 12 months.

Tibolona Aristo and Tibocina are generic medicines based on a 'reference medicine', Liviella, which is authorised in Germany.

Why were Tibolona Aristo and Tibocina reviewed?

Aristo Pharma GmbH submitted Tibolona Aristo and Tibocina to the Spanish medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Spain) 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 Belgium, Germany and the Netherlands).

However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 31 October 2013.

e data submitted to show that Tibolona Aristo and Tibocina were 'bioequivalent' to the reference medicine, Liviella. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. In particular, Germany considered that these data were not reliable because of failings in the way the study samples were identified and registered and the cold storage and transport of the samples were recorded. This means that storage conditions could potentially have been inadequate leading to the degradation of the active substance, making the samples inadequate for testing.

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 been shown. The company had supplied additional evidence to indicate that the study samples had been stored and maintained under adequate temperature conditions, further supported by the concentrations recorded in the bioequivalence study. The CHMP therefore concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks and recommended that the marketing authorisations be granted in the concerned Member States.

The European Commission issued a decision on 05 March 2014.

Questions and answers on Tibolona Aristo and Tibocina and associated names (tibolone, tablet, 2.5 mg)

Reference Number: EMA/793605/2013

Key facts

About this medicine

• Approved name:
  Tibolona Aristo and Tibocina and associated names
• International non-proprietary name (INN) or common name:
  tibolone
• Associated names:
  • Tibolon Aristo
  • Tibolinia

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1389 and EMEA/H/A-29/1390
• 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:
  19/12/2013
• EC decision date:
  05/03/2014

All documents

Opinion provided by Committee for Medicinal Products for human Use

Tibolona Aristo and Tibocina and associated names Article-29(4) referral - Assessment report

Reference Number: EMA/41126/2014

European Commission final decision

Tibolona-Article 29(4) referral - Annex I

Tibolona-Article 29(4) referral - Annex II

Tibolona-Article 29(4) referral - Annex III

Tibocina Article-29(4) referral - Annex I

Tibocina-Article 29(4) referral - Annex II

Tibocina-Article 29(4) referral - Annex III

Questions and answers on Tibolona Aristo and Tibocina and associated names (tibolone, tablet, 2.5 mg)

Reference Number: EMA/793605/2013

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.