Plasma-derived medicines policies
Each plasma-derived medicine is unique, due to the pharmacological and manufacturing differences across different brands and to each patient’s unique response to the treatments. These therapies are non-interchangeable, sole-source biologics, therefore it is essential that patients have continued access to their specific therapy. One-size-fits-all policies are not suitable for plasma-derived medicines and endanger patient health.
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Council of Europe
“[...] Take into account that human normal immunoglobulin therapeutic products differ from one another in terms of production processes, which might have an impact on specificationsand clinical performance.”
Council of Europe, Resolution CM/Res(2015)2 on principles concerning human normal immunoglobulin therapies for immunodeficiency and other diseases (Adopted by the Committee of Ministers on 15 April 2015 at the 1225th meeting of the Ministers’ Deputies)
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Council of Europe
“[...] Take into account that human normal immunoglobulin therapeutic products differ from one another in terms of production processes, which might have an impact on specificationsand clinical performance.”
Council of Europe, Resolution CM/Res(2015)2 on principles concerning human normal immunoglobulin therapies for immunodeficiency and other diseases (Adopted by the Committee of Ministers on 15 April 2015 at the 1225th meeting of the Ministers’ Deputies)
All
Plasma-derived medicines policies
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