Tibolona Aristo and Tibocina and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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.
Key facts
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About this medicine
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|---|---|
| Approved name |
Tibolona Aristo and Tibocina and associated names
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| International non-proprietary name (INN) or common name |
tibolone
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| Associated names |
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-29/1389 and EMEA/H/A-29/1390
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| 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. |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
19/12/2013
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| EC decision date |
05/03/2014
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Tibolona-Article 29(4) referral - Annex I (PDF/21.77 KB)
First published: 08/04/2014
Last updated: 08/04/2014
Tibolona-Article 29(4) referral - Annex II (PDF/26.69 KB)
First published: 08/04/2014
Last updated: 08/04/2014
Tibolona-Article 29(4) referral - Annex III (PDF/16.11 KB)
First published: 08/04/2014
Last updated: 08/04/2014
Tibocina Article-29(4) referral - Annex I (PDF/25.08 KB)
First published: 08/04/2014
Last updated: 08/04/2014
Tibocina-Article 29(4) referral - Annex II (PDF/27.53 KB)
First published: 08/04/2014
Last updated: 08/04/2014
Tibocina-Article 29(4) referral - Annex III (PDF/16.64 KB)
First published: 08/04/2014
Last updated: 08/04/2014
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.