Calcitonins - referral

Current status

European Commission final decision

Overview

Calcitonin has been used since 1973 when injectable forms became available for the treatment of osteoporosis-related indications. In 1987 preparations for intranasal use were put on the market. The indications for which calcitonin has been approved varied within the Member States and included, prevention and treatment of osteoporosis from different aetiologies, bone pain due to osteolysis or osteoporotic fractures, Paget's disease, hypercalcaemia of malignancy and Sudeck syndrome. Calcitonin from different origins is approved in all EU Member States and has been used in clinical practice for more than 20 years.

In April 2000, The Netherlands notified the EMEA and submitted grounds for a referral under Article 31 of Council Directive 2001/83/EC (corresponding to Article 12 of Directive 75/319/EC as amended for referrals triggered before 18 December 2001), which is appended to this opinion.

The Marketing Authorisation Holders provided written explanations by 4 September 2000. Supplementary information was provided by 14 September 2001 and 1 March 2002. Oral explanations were given by the Marketing Authorisation Holders on 16 October 2002.

Upon consideration of all available data, the CPMP adopted an opinion on 21 November 2002. This opinion recommended the maintenance of the Marketing Authorisations for calcitonins containing medicinal in the indications stated in the Summary of Product Characteristics are set out in Annex III.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III.

On the basis of the CPMP Opinion, the European Commission issued a Decision on 13 June 2003.

Opinion following an Article 31 referral for Calcitonins containing medicinal products International Non-Proprietary Name (INN): Calcitonin: Background information and Annexes I,II

Adopted Reference Number: CPMP/867/04

Key facts

About this medicine

• Approved name:
  Calcitonins
• International non-proprietary name (INN) or common name:
  calcitonin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/867/04
• Type:
  Article 31 referrals

  This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Key dates and outcomes

• CHMP opinion date:
  22/11/2002
• EC decision date:
  12/06/2003

All documents

Calcitonins - Article 31 referral - Annex III

Adopted

Opinion following an Article 31 referral for Calcitonins containing medicinal products International Non-Proprietary Name (INN): Calcitonin: Background information and Annexes I,II

Adopted Reference Number: CPMP/867/04

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.