www.aquieuropa.com<\/p>\n
La Agencia Europea de Medicamentos ha recibido la solicitud de la farmac\u00e9utica Pfizer para poder iniciar la revisi\u00f3n del medicamento antiviral contra la Covid-19 Paxlovid. Aunque el medicamento a\u00fan no est\u00e1 aprobado la EMA ya emiti\u00f3 en diciembre una recomendaci\u00f3n para su uso en caso de emergencia. Este lunes el presidente del Gobierno, Pedro S\u00e1nchez, ha anunciado que comprar\u00e1 344.000 dosis del medicamento.<\/p><\/blockquote>\n
La aprobaci\u00f3n del uso de un medicamento para evitar que la enfermedad provocada por el virus de la Covid-19 derive en casos graves podr\u00eda estar cerca.La EMA ha comenzado a evaluar una solicitud de autorizaci\u00f3n de comercializaci\u00f3n condicional para el medicamento antiv\u00edrico oral Paxlovid (PF-07321332 y ritonavir) de la farmac\u00e9utica Pifzer.<\/p>\n
El medicamento iria destinado a enfermos de la Covid-19 con diagnostico de leve a moderado en pacientes adultos y adolescentes (a partir de 12 a\u00f1os que pesan al menos 40 kg) que tienen un alto riesgo de progresi\u00f3n a Covid19 grave.<\/p>\n
La EMA evaluar\u00e1 los beneficios y riesgos de Paxlovid en un plazo reducido y podr\u00eda emitir una opini\u00f3n en unas semanas, dependiendo de si los datos presentados son lo suficientemente s\u00f3lidos y si se requiere m\u00e1s informaci\u00f3n para respaldar la evaluaci\u00f3n.<\/p>\n
Un plazo tan r\u00e1pido solo es posible porque el comit\u00e9 de medicamentos humanos (CHMP) de la EMA ya ha comenzado una revisi\u00f3n de los datos sobre el medicamento durante una revisi\u00f3n continua, que incluy\u00f3 datos de estudios cl\u00ednicos, animales y de laboratorio, as\u00ed como datos sobre la calidad de los medicamentos. la medicina. Adem\u00e1s, el CHMP evalu\u00f3 los resultados provisionales del estudio principal sobre el uso de Paxlovid en pacientes con COVID-19 no hospitalizados y no vacunados que ten\u00edan una enfermedad sintom\u00e1tica y al menos una afecci\u00f3n subyacente que los pon\u00eda en riesgo de sufrir una enfermedad grave.1<\/p>\n
Paralelamente, el comit\u00e9 de seguridad de la EMA (PRAC) inici\u00f3 la evaluaci\u00f3n del plan de gesti\u00f3n de riesgos (PGR) propuesto por la empresa, que describe las medidas para identificar, caracterizar y minimizar los riesgos del medicamento. Adem\u00e1s, de acuerdo con los plazos acelerados para los productos COVID-19, el comit\u00e9 de medicamentos para ni\u00f1os (PDCO) de la EMA emiti\u00f3 su opini\u00f3n sobre el plan de investigaci\u00f3n pedi\u00e1trica (PIP) de la empresa, que describe c\u00f3mo se debe desarrollar y estudiar el medicamento para su uso en ni\u00f1os.<\/p>\n
En caso de que los datos adicionales presentados con la solicitud de autorizaci\u00f3n de comercializaci\u00f3n condicional sean suficientes para que el CHMP llegue a la conclusi\u00f3n de que los beneficios de Paxlovid superan sus riesgos en el tratamiento de COVID 19, la EMA se mantendr\u00e1 en estrecho contacto con la Comisi\u00f3n Europea para acelerar la decisi\u00f3n de concesi\u00f3n de una autorizaci\u00f3n de comercializaci\u00f3n condicional. en todos los Estados miembros de la UE y del EEE.<\/p>\n","protected":false},"excerpt":{"rendered":"
Espa\u00f1a | Noti-America.com www.aquieuropa.com LA EMA EMPIEZA A EVALUAR EL ANTIVIRAL CONTRA LA COVID-19 DE PFIZER por Redacci\u00f3n La Agencia Europea de Medicamentos ha recibido la solicitud de la farmac\u00e9utica Pfizer para poder iniciar...<\/p>\n","protected":false},"author":2,"featured_media":9086,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"image","meta":{"_acf_changed":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_10219548024599422_1632221337088128":"","twitter_242054905_242054905":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[663],"tags":[],"class_list":["post-9085","post","type-post","status-publish","format-image","has-post-thumbnail","hentry","category-actualidad","post_format-post-format-image"],"acf":[],"yoast_head":"\n
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