Calcitonin

Current status:
European Commission final decision

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

Approved name
Calcitonin
International non-proprietary name (INN) or common name
calcitonin
Reference number
EMEA/H/A-31/1291
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.

Status
European Commission final decision
Opinion date
19/07/2012
EC decision date
13/02/2013

All documents

Document description

  • 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:

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