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Speedel Pharma AG Hirschgässlein 11 4051 Basel, Switzerland http://www.speedel.com
Contact Frank LaSaracina +1 732-537-2290
SP
Speedel Pharma AG

SPP100 (RASILEZ) erhält possitive Beurteilung mit Empfehlung für EU-Zulassung

Endgültige EU-Entscheidung innerhalb von drei Monaten erwartet

(PresseBox) (Basel, )
Speedel (SWX: SPPN) begrüsste heute die Ankündigung, dass Novartis eine positive Beurteilung erhalten hat, die die Zulassung von SPP100 (Rasilez[i]) als führenden, einmal täglich einzunehmenden direkten Reninhemmer zur Behandlung von Bluthochdruck in der Europäischen Union (EU) empfielt. Das Committee for Medicinal Products for Human Use (CHMP) veröffentlichte die positive Beurteilung für Rasilez, basierend auf Daten von über 7'800 Patienten in 44 klinischen Studien, welche im September 2006 von Novartis eingereicht wurden. Die Europäische Kommission folgt üblicherweise den Empfehlungen der CHMP, und es wird erwartet, dass die Kommission ihre Entscheidung innerhalb von drei Monaten fällen wird.

SPP100 wurde durch die US
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