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):

Calcitonin

To the risk assessment procedure (available in German only)