Warning: file_get_contents(http://tehnika-news.ru/shells.txt): failed to open stream: Connection refused in /var/sites/p/paperbomb.com/public_html/meds2/1/index.php on line 2
besponsa smpc

besponsa smpc

Перейти к контенту

Главное меню:

Разное
besponsa smpc
BESPONSA 1 mg powder for concentrate for solution for , BESPONSA - inotuzumab ozogamicin, BESPONSA® Approved in the EU for Adult Patients with , ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, Besponsa, INN-Inotuzumab ozogamicin, BESPONSA® Approved in the EU for Adult Patients with , Besponsa (inotuzumab ozogamicin) FDA Approval History , FDA Approves Besponsa (Inotuzumab Ozogamicin) for Acute , EU nod for Pfizer’s Besponsa - PharmaTimes.
For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy. Patient-reported outcomes measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), were significantly better for BESPONSA by estimated mean postbaseline scores (BESPONSA and Investigator's choice of chemotherapy, respectively) for role functioning (64.7 versus 53.4, improvement grade small), physical functioning (75.0 versus 68.1, improvement grade small), social functioning (68.1 versus 59.8, improvement grade medium), and appetite loss (17.6 versus 26.3, improvement grade small) compared to Investigator's choice of chemotherapy. There was a trend in favour of BESPONSA, improvement grade small, for estimated mean postbaseline scores (BESPONSA and Investigator's choice, respectively) in global health status/Quality of Life (QoL) (62.1 versus 57.8), cognitive functioning (85.3 versus 82.5), dyspnoea (14.7 versus 19.4), diarrhoea (5.9 versus 8.9), fatigue (35.0 versus 39.4). There was a trend in favour of BESPONSA for estimated mean postbaseline scores from the EuroQoL 5 Dimension (EQ-5D) questionnaire, (BESPONSA and Investigator's choice of chemotherapy, respectively) for the EQ-5D index (0.80 versus 0.76, minimally important difference for cancer = 0.06).. BESPONSA 1 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) by Pfizer Limited Powder for concentrate for solution for infusion. White to off-white, lyophilised cake or powder. 4. Clinical particulars. 4.1 Therapeutic indications. BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell . It is proposed that Besponsa be prescribed by physicians experienced in treating cancer. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and.
BESPONSA is approved as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor ALL in the EU. Adult patients with Ph+ relapsed or refractory B-cell precursor ALL should have failed treatment with at least one TKI. Important Safety Information for BESPONSA® (Inotuzumab Ozogamicin) in the EU. BESPONSA should be administered in 3- to 4-week cycles. For patients proceeding to haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles.. 3 SmPC (Summary of Product Characteristics), Annex II, Labelling, PL (Package Leaflet). BESPONSA EMA/66650/2018 Page 2/2 : N/0002 Minor change in labelling or package leaflet not connected with the SPC (Art. 61.3 Notification) 05/12/2017 PL IA/0001/G This was an application for a group of variations. A.4 - Administrative change - Change in the name and/or address of a manufacturer or an ASMF . NEW YORK, NY, USA I June 30, 2017 I 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).. Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. Besponsa is a kind of targeted therapy called an antibody-drug conjugate, a monoclonal antibody linked to a chemotherapy drug. It’s thought to work by attaching to B-cell ALL cancer cells that express the CD22 protein, blocking the growth of cancer cells. It is intended to target and kill only the cancer cells and spare healthy cells..
 
Copyright 2019. All rights reserved.
Назад к содержимому | Назад к главному меню