EMA recommends approval of higher-strength insulin

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommanded 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.

The strength of 100 units/ml has for many years been the only strength available for all insulin products. But from the beginning of 2013, it is expected that the new, higher-strength version will be marketed in Europe. It will be marketed under the trade name Tresiba.

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