EMA starts assessing compassionate use of unauthorised medicines

Published: 3-Feb-2010
Regulatory

Assessments are under way by the European Medicines Agency (EMA) of EU government plans to allow compassionate use of medicines that have yet to receive full market authorisation.


Assessments are under way by the European Medicines Agency (EMA) of EU government plans to allow compassionate use of medicines that have yet to receive full market authorisation. EMA has released its first such assessment - of a Finland policy to allow the use of the new Tamiflu IV.

The agency said this should be considered only "to treat critically ill adults and children older than 1 year of age having a life-threatening condition" due to H1N1 or seasonal flu virus, where other drugs are failing.

EMA will publish a series of opinions on other compassionate use programmes after detailed assessments.

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