Search results for " European Medicines Agency"

showing 4 items of 4 documents

Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the Severe Asthma Network in Italy (SANI)

2020

According to the data derived from several national and international registries, including SANI (Severe Asthma Network Italy), and considering the strong impact that frequent or regular use of oral corticosteroid has on quality of life (QoL) of severe asthmatics, as well as on the costs for managing corticosteroid-related diseases, oral corticosteroid sparing up to withdrawal should be considered a primary outcome in the management of severe asthma. New biologics have clearly demonstrated that this effect is possible, with concomitant reduction in the rate of exacerbations and in symptom control. Then, there is no reason for using so frequently oral corticosteroid before having explored al…

ISAR International Severe Asthma RegistrySHARPPediatricsSevere asthmaSA severe asthmaBiologics Oral corticosteroids Real-life Registr Severe asthmaOmalizumabforced expiratory volume in the 1st secondFood &ampGrading of Recommendations Assessmentchronic rhinosinusitis with nasal polyposisFEV1chemistry.chemical_compound0302 clinical medicineQuality of lifeEMAReal WorldEuropean Medicines AgencyBiologics; Oral corticosteroids; Real-life; Registr; Severe asthmaOral corticosteroidsFDA Food & Drug AdministrationImmunology and Allergy030223 otorhinolaryngologySevere Heterogeneous Asthma Research collaborationmusculoskeletal neural and ocular physiologyReal-lifeCRSwNPOCSsBenralizumabDupilumabCRSwNP chronic rhinosinusitis with nasal polyposisGRADESHARP Severe Heterogeneous Asthma Research collaboration Patient-centredSevere Asthma Network in ItalyFDAmedicine.drugPulmonary and Respiratory Medicinelcsh:Immunologic diseases. Allergymedicine.medical_specialtyDrug AdministrationGINA Global Initiative for AsthmaRW Real WorldImmunologymacromolecular substancesRWSettore MED/10 - Malattie Dell'Apparato RespiratorioBiologicsInternational Severe Asthma RegistryISAR03 medical and health sciencesSADisease registrySARP Severe Asthma Research ProgramPatient-centredmedicineAsthmabusiness.industrySettore MED/09 - MEDICINA INTERNASANI Severe Asthma Network in ItalySANIBiological productmedicine.diseaseOCSs Oral CorticoSteroidsGINASARPSevere Asthma Research ProgramFEV1 forced expiratory volume in the 1st second030228 respiratory systemchemistrynervous systemRegistrEMA European Medicines AgencyDevelopment and EvaluationSevere asthma Biologics Oral corticosteroids Real-life Registrbusinesslcsh:RC581-607Global Initiative for AsthmaMepolizumabGRADE Grading of Recommendations Assessment Development and Evaluation
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French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge.

2021

International audience; In this special issue, we present the main highlights of the first weeks of pharmacovigilance monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented situation in France: the deployment of a vaccination during an epidemic period with the aim of vaccinating the entire population and the intense pharmacovigilance and surveillance of these vaccines still under conditional marketing authorizations. In this unprecedented situation, the cross approach and interaction between the French pharmacovigilance network and French National Agency for the Safety of Medicines and Health Products (ANSM) has been optimized to provide a real-time safety related …

MaleEuropean levelCOVID-19 VaccinesCoronavirus disease 2019 (COVID-19)Adverse drug reactions030226 pharmacology & pharmacyArticleADR adverse drug reaction03 medical and health sciencesPharmacovigilance0302 clinical medicinePharmacovigilancePandemicMedicineAdverse Drug Reaction Reporting SystemsHumansPharmacology (medical)Drug reactionPEG polyethylene glycolEntire populationVaccinesbusiness.industrySOC system organ classSARS-CoV-2COVID coronavirus disease[SCCO.NEUR]Cognitive science/Neuroscience[SCCO.NEUR] Cognitive science/NeuroscienceAuthorizationCOVID-19Middle Agedmedicine.diseaseRPVC Regional Pharmacovigilance CenterVaccinationEMA European Medicines AgencyFemaleMedical emergencyFrancebusinessANSM Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)OrganizationTherapie
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Efficacy and Safety of IQYMUNE®, a Ten Percent Intravenous Immunoglobulin in Adult Patients With Chronic, Primary Immune Thrombocytopenia

2018

Background: Intravenous immunoglobulin (IVIG) IQYMUNE® is a highly purified 10% IVIG that was assessed using the new stringent definition of response described in the revised guideline on the clinical investigation of IVIG. The efficacy and the safety of IQYMUNE® were investigated in adult patients with chronic primary immune thrombocytopenia (ITP). Methods: In this phase III multinational, multicentre, prospective, uncontrolled, open-label, single-arm study, adult patients with a baseline platelet count < 30 × 10 9 /L were treated with IVIG 10% at a dose of 2 g/kg body weight administered over 2 consecutive days. The primary endpoint was Response over the study period and was defined accor…

medicine.medical_specialtyEuropean Medicines Agency guidelinesPlatelet countRenal functionHigh dose030204 cardiovascular system & hematologyGastroenterology03 medical and health sciencesIntravenous immunoglobulin; High dose; Immune thrombocytopenia; Response; European Medicines Agency guidelines; Platelet count; Bleeding assessment; Infusion rate0302 clinical medicineInfusion rateInternal medicinemedicineClinical endpointPlateletAdverse effectIntravenous immunoglobulinbiologybusiness.industryResponseGuidelineImmune thrombocytopeniaImmune thrombocytopenia030220 oncology & carcinogenesisConcomitantbiology.proteinBleeding assessmentOriginal ArticleAntibodybusinessJournal of Hematology
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“The European Medicines Agency (EMEA) guideline on oncology drug development”

2007

Settore MED/06 - Oncologia Medicadrug development European Medicines Agency
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