Calcitonin
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 19 July 2012, the European Medicines Agency (EMA) completed a review of the benefits and risks of calcitonin-containing medicines, concluding that there was evidence of a small increased risk of cancer with long-term use of these medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that they should only be authorised for short-term use in Paget's disease, acute bone loss due to sudden immobilisation and hypercalcaemia caused by cancer. The Committee also concluded that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
After a re-examination, the Committee confirmed its recommendation on 15 November 2012.
Key facts
About this medicine
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Approved name |
Calcitonin
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International non-proprietary name (INN) or common name |
calcitonin
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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-31/1291
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Type |
Key dates and outcomes
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CHMP opinion date |
19/07/2012
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EC decision date |
13/02/2013
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All documents
Questions and answers on the review of calcitonin-containing medicines (PDF/109.29 KB)
First published: 20/07/2012
Last updated: 20/07/2012
EMA/476001/2012
Calcitonin: Product information as approved by the CHMP on 19 July 2012, pending endorsement by the European Commission (PDF/27.35 KB)
First published: 20/07/2012
Last updated: 20/07/2012
Opinion provided by Committee for Medicinal Products for Human Use
Questions and answers on the review of calcitonin-containing medicines - Outcome of re-examination (PDF/76.77 KB)
First published: 16/11/2012
Last updated: 16/11/2012
Calcitonin: Product information as approved by the CHMP on 15 November 2012, pending endorsement by the European Commission (PDF/25.63 KB)
First published: 16/11/2012
Last updated: 16/11/2012
European Commission final decision
Calcitonin Article-31 referral - Annex I (PDF/515.06 KB)
First published: 19/07/2013
Last updated: 19/07/2013
Calcitonin Article-31 referral - Annex II (PDF/108.4 KB)
First published: 19/07/2013
Last updated: 19/07/2013
Calcitonin Article-31 referral - Annex III (PDF/38.7 KB)
First published: 19/07/2013
Last updated: 19/07/2013
Calcitonin Article-31 referral - Annex IV (PDF/23.1 KB)
First published: 19/07/2013
Last updated: 19/07/2013
Assessment report for calcitonin containing medicinal products (PDF/492.38 KB)
First published: 19/07/2013
Last updated: 19/07/2013
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.