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Home > EMA recommends approval of higher-strength insulin

EMA recommends approval of higher-strength insulin [1]

Submitted by gbassetto on Mon, 12/03/2012 - 10:55

The European Medicines Agency [2]’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.

Click here [3] to access to full press release.



Source URL: http://www.idf.org/ema-recommends-approval-higher-strength-insulin

Links:
[1] http://www.idf.org/ema-recommends-approval-higher-strength-insulin
[2] http://www.ema.europa.eu/ema/
[3] http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/10/news_detail_001638.jsp&mid=WC0b01ac058004d5c1