CHMP recommends approval of Giapreza for refractory hypotension
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Giapreza (angiotensin II acetate), from La Jolla Pharmaceutical, intended for the treatment of refractory hypotension in adults with septic or other distributive shock. Giapreza will be available as a 2.5 mg/ml concentrate for solution for infusion. The benefit with Giapreza is its ability to increase blood pressure in patients with septic and distributive shock. The most common side effects are thromboembolic events, transient hypertension, tachycardia and peripheral ischaemia.
The full indication is: “Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies."
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