Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 16 April 2018

Indication(s)

Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).

Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

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Category Value
Agency product number EMEA/H/C/001207
Orphan designation No
Date First Approved 15-06-2011
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Shire Services BVBA