Asunto(s)
Cannabidiol/normas , Dronabinol/normas , Aprobación de Drogas , Extractos Vegetales/normas , Cannabidiol/administración & dosificación , Cannabidiol/farmacología , Dronabinol/administración & dosificación , Dronabinol/farmacología , Combinación de Medicamentos , Quimioterapia Combinada , Humanos , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Noruega , Vaporizadores Orales , Extractos Vegetales/administración & dosificación , Extractos Vegetales/farmacologíaAsunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Anafilaxia/inducido químicamente , Androstanoles/efectos adversos , Anestesia/efectos adversos , Humanos , Rocuronio , Estados Unidos , Bromuro de Vecuronio/efectos adversosAsunto(s)
Aprobación de Drogas , Glucosamina , Glucosamina/efectos adversos , Glucosamina/uso terapéutico , Humanos , NoruegaRESUMEN
In 2000, regulation on orphan medicinal products was adopted in the European Union with the aim of benefiting patients who suffer from serious, rare conditions for which there is currently no satisfactory treatment. Since then, more than 850 orphan drug designations have been granted by the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products (COMP), and more than 60 orphan drugs have received marketing authorization in Europe. Here, stimulated by the tenth anniversary of the COMP, we reflect on the outcomes and experience gained in the past decade, and contemplate issues for the future, such as catalysing drug development for the large number of rare diseases that still lack effective treatments.