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Calcitonin: restricted use
2020.03.19
Active substance: Calcitonin
19.03.2020 - Notice within the graduated plan procedure ("Stufenplanverfahren") - Extension of the suspension of the marketing authorisations
With regard to the intranasal dosage form for the osteoporosis indication, the suspension of marketing authorisations has been extended until April 1, 2022.
29.03.2018 - Notice within the graduated plan procedure ("Stufenplanverfahren")
With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2020.
08.03.2016 - Notice within the graduated plan procedure ("Stufenplanverfahren")
With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2018.
12.04.2013 - Notice within the graduated plan procedure ("Stufenplanverfahren")
In order to implement the decision of the EU Commission on calcitonin-containing drugs for injection, the BfArM has ordered extensive changes to the product information with regard to the cancer risk, in particular for long-term use.
02.08.2012 - CHMP opinion
Due to an increased risk of cancer the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends restricting the indication of medicinal products containing calcitonin, discontinuing intranasal use for treatment of osteoporosis and limiting the use as well as reducing the dosage of these medicinal products.
Further information
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
To the risk assessment procedure (available in German only)