Off-label use of medicines

30 January 2015

In a new report, the Danish Health and Medicines Authority highlights the monitoring of the safety of off-label use of medicines in Denmark.

Off-label use of medicines may include giving a medicinal product for a purpose other than the purpose it is approved for or administering a medicinal product in other doses than the recommended doses.

Off-label treatment is widespread in Denmark and the rest of the world. There are many reasons for the widespread off-label use of medicines. In some cases, off-label use is the only possible treatment, in other cases approved treatments are rejected in favour of medicine, because it may be of greater benefit to the patient.

In recent years, we have seen an increasing focus on the monitoring of the safety of off-label use of medicines. The Danish Health and Medicines Authority and the EU have increased attention on the use of medicines for treatments that are not covered by the medicine's authorised summary of product characteristics and on the need for the development of improved monitoring of safety in connection with off-label use of medicines.

Link

Report on monitoring the safety of off-label use of medicines in Denmark (in Danish only)

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