Press Release: European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), in October 2012, made a recommendation to give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It is introduced in a pre-filled pen in two formulations – 100 units/ml and 200 units/ml.

This is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, for many years the only strength of insulin available across the EU. It will be marketed under the trade name Tresiba.

EMA: Press Release: EMA/CHMP/675745/2012 (19.10.12) http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/10/WC500134111.pdf

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