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besponsa ema label

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besponsa ema label
Besponsa - European Medicines Agency - ema.europa.eu, Welcome to BESPONSA® | BESPONSA®, BESPONSA - inotuzumab ozogamicin - ema.europa.eu, Besponsa: Is this really a viable new treatment for ALL , BESPONSA 1 mg powder for concentrate for solution for , Reference ID: 4140675 - Food and Drug Administration, European Medicines Agency decision - ema.europa.eu, Besponsa (inotuzumab ozogamicin) | TheSocialMedwork, Package leaflet: Information for the user BESPONSA 1 mg .
BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This condition can occur during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had elevated liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they: . Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL).. BESPONSA is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age..
EMA/CHMP/245560/2017 . Committee for Medicinal Products for Human Use (CHMP) Summary of opinion. 1 (initial authorisation) 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 . August 18, 2017 – B-cell precursor acute lymphoblastic leukemia is a aggressive and rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell.. The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2). Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL.. BESPONSA is a CD22-directed antibody -drug conjugate (ADC) indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. European Medicines Agency decision EMA/801040/2017 Page 3/3 Has adopted this decision: Article 1 Changes to the agreed paediatric investigation plan for inotuzumab ozogamicin (Besponsa), powder for. The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals were mainly based on a randomized, open-label study (INO-VATE ALL - NCT01564784) in which Besponsa was tested against chemotherapy..
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