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Galenica AG

Velphoro® (PA21) erhält positives CHMP-Gutachten

(PresseBox) (Bern, )
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- Velphoro® (PA21) in der Europäischen Union zur Zulassung für die Behandlung von Hyperphosphatämie bei dialysepflichtigen erwachsenen Patienten mit chronischer Niereninsuffizienz empfohlen

Velphoro® (Sucroferric Oxyhydroxide) hat vom Ausschuss für Humanarzneimittel (CHMP) der europäischen Registrierungsbehörde European Medicines Agency (EMA) ein positives Gutachten erhalten. Der Ausschuss empfiehlt, das Medikament zur Kontrolle des Serum-Phosphatspiegels bei erwachsenen Patienten mit chronischer Niereninsuffizienz (CKD) unter Hämodialyse (HD) oder Peritonealdialyse (PD) in den 28 EU-Länder zuzulassen. Der endgültige Zulassungsentscheid der Europäischen Kommission wird im Herbst diesen Jahres erwartet.

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