- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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.
|International non-proprietary name (INN) or common name||
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.
European Commission final decision
|EC decision date||
Opinion following an Article 31 referral for Calcitonins containing medicinal products International Non-Proprietary Name (INN): Calcitonin: Background information and Annexes I,II (PDF/355.78 KB)Adopted
First published: 28/02/2004
Last updated: 28/02/2004
Calcitonins - Article 31 referral - Annex III (PDF/203.29 KB)Adopted
First published: 02/03/2004
Last updated: 02/03/2004
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies