Data from EMC - Curated by Toby Galbraith - Last updated 19 May 2017
EMA (European Medicines Agency)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
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This study will optimize the safety and efficacy of chronic administration of idelalisib in participants with follicular lymphoma (FL) and evaluate the overall safety profile of idelalisib...
Added 1 month ago
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse...
Added 4 years ago
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A (Kids ALONG)
The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc)...
Added 5 years ago
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B (Kids B-LONG)
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein...
Added 6 years ago
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein in Previously Treated Subjects With Severe Hemophilia A
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm...
Added 7 years ago
Pharmacokinetics, Efficacy, and Safety of Nonacog Alfa in Previously Treated Patients with Moderately Severe to Severe Hemophilia B.
Purpose: Nonacog alfa, a recombinant factor IX (FIX) product, is used for FIX replacement in the treatment and prevention of...
Added 1 year ago
Is there a difference in efficacy, safety, and cost-effectiveness between 3-factor and 4-factor prothrombin complex concentrates among trauma patients on oral anticoagulants?
The aim of this study was to compare the efficacy, safety, and cost-effectiveness of 3-factor prothrombin complex concentrate vs 4-factor prothrombin complex concentrate in trauma patients requiring reversal of oral anticoagulants.
Added 7 months ago
Reversibility of Apixaban Anticoagulation with a Four-Factor Prothrombin Complex Concentrate in Healthy Volunteers.
It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state.
Added 10 months ago
This guideline covers the assessment for and management of blood transfusions in adults, young people and children over 1 year...
Added 1 year ago
The aim of this guideline is to provide recommendations for the haematological management of major haemorrhage in any clinical situation,...
Added 1 year ago
The diagnosis and management of von Willebrand disease: a United Kingdom Haemophilia Centre Doctors Organization guideline approved by the British Committee for Standards in Haematology
The objective of this guideline is to provide healthcare professionals with clear guidance on the diagnosis and management of patients...
Added 2 years ago
|Agency product number||EMEA/H/C/003825|
|Date First Approved||18-02-2016|
|Type||Medicinal product subject to restricted medical prescription|
|Marketing authorisation holder||Bayer Pharma AG|
|Warnings||This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions|