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Inotuzumab Ozogamicin - Besponsa® - G-BA early benefit , Nutzenbewertungsverfahren zum Wirkstoff - g-ba.de, inotuzumab ozogamicin (Besponsa) - scottishmedicines.org.uk, BESPONSA - inotuzumab ozogamicin, BESPONSA® Approved in the EU for Adult Patients with , Assessment report - ema.europa.eu, Besponsa (inotuzumab ozogamicin) - Moda Health, Besponsa (inotuzumab ozogamicin), Pfizer's Besponsa Is Yet Another Win for the Biopharma .
INNInotuzumab OzogamicinMarkennameBesponsa®HerstellerPfizer Pharma GmbHATC-CodeL01XC26Zweckmäßige VergleichstherapieentfälltIndikationsgebietONCOORPHANOnkologische ErkrankungenIndikationBESPONSA® ist indiziert als Monotherapie zur Behandlung von Erwachsenen mit rezidivierter oder refraktärer CD22-positiver B-Vorläufer ALL (akuter lymphatischer Leukämie). Erwachsene Patienten mit Philadelphia-Chromosom-positiver (Ph+) rezidivierter oder refraktärer B-Vorläufer ALL sollten eine vorhergehende erfolglose Behandlung mit mindestens einem Tyrosinkinase-Inhibitor (TKI) aufweisen.. The AMNOG monitor is a subscription-based service for pharmaceutical manufacturers and institutions. It offers a wealth of in-depth information on all early benefit assessments in Germany.. Die Frist zur Abgabe einer schriftlichen Stellungnahme ist am 06.11.2017 abgelaufen..
inotuzumab ozogamicin (BESPONSA®) is accepted for restricted use within NHSScotland. Indication under review: as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).. Besponsa . inotuzumab ozogamicin . On 21 April 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a . marketing authorisation for the medicinal product Besponsa, intended for the treatment of adults with acu te lymphoblastic leukaemia . Besponsa was designated as an orphan medicinal product on 7 June 2013. The applicant for . Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved BESPONSA® (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). This indication includes treatment of adults. ‘BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL)’. Following the CHMP positive opinion on this marketing authorisation, the Committee for Orphan Medicinal. Moda Health Plan, Inc. Medical Necessity Criteria Page 3/3 3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) inotuzumab ozogamicin.. Page 3 | BESPONSA (inotuzumab ozogamicin) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy without approval..
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