The European Immunization Week, which takes place every year between 24 and 30 April, is a great opportunity to remind ourselves how lucky we are to be living in a world where vaccines exist. We have vaccines against more than 20 life-threatening diseases including polio, diphtheria, tetanus, whooping cough, COVID-19, influenza and measles. It is [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.En octubre de 2019 la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informó de la retirada, como medida de precaución, de todos [...]
The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in [...]
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its January 2022 meeting. The antiviral Paxlovid (PF-07321332 / ritonavir) received a positive opinion from the Committee for a conditional marketing authorisation for the treatment of COVID-19. More details are available in a separate news announcement. The CHMP gave a positive opinion for the new gene therapy Breyanzi* (lisocabtagene maraleucel) for the treatment [...]
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the Interagency Food Safety Analytics Collaboration — a collaboration between the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the Food Safety and Inspection Service — has published its priorities for calendar [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. En este informe se actualiza la información sobre los siguientes asuntos de seguridad: Se actualiza la información del riesgo de miocarditis/pericarditis [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge nuevos medicamentos, cambios de especial interés en medicamentos ya autorizados, información sobre seguridad y otra información de interés. En la sección [...]
EMA’s human medicines committee (CHMP) has endorsed findings of a review which concluded that there is no evidence Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML). Zynteglo, a gene therapy for the blood disorder beta thalassaemia, uses a viral vector (or modified virus) to deliver a working gene into the patient’s blood [...]
The Medicines and Healthcare products Regulatory Agency is playing a pivotal role helping to ensure that the UK remains one of the best places in the world to deliver safe, cutting-edge research. The unprecedented challenges of the last 18 months have shone a spotlight on UK clinical research. Through a heightened spirit of collaboration and [...]
Comme annoncé par le ministre chargé de la santé le 28 mai 2021, l’accès à la prophylaxie pré-exposition au VIH a été simplifié avec la possibilité d’une initiation par tout médecin. Jusque-là, seuls les médecins exerçant à l’hôpital ou dans un centre gratuit d'information, de dépistage et de diagnostic (CeGIDD) pouvaient la prescrire. Ceci est effectif [...]
Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant [...]
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal). The Tiger Tech COVID Plus Monitor is [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La AEMPS junto con otras agencias nacionales, la EMA y la industria farmacéutica, están trabajando para la implementación de los estándares [...]
Information destinée aux services d’urgence, SAMU/SMUR, de réanimation/soins intensifs, de neurologie et de neurochirurgie, de pédiatrie, et aux pharmaciens hospitaliers Les guides posologiques de la spécialité PRODILANTIN 75 mg/ml sont de nouveau envoyés aux professionnels de santé afin notamment de détailler les modalités pour l’administration de doses de charge chez l’enfant de plus de 5 [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. No se ha identificado en España o en la Unión Europea ninguna posible reacción adversa hasta ahora desconocida que pueda ser [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La AEMPS ha elaborado un plan de vigilancia de la seguridad de las vacunas frente a la COVID-19 para intensificar las actividades de [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La AEMPS informa de que ya está vigente la instrucción nº1/2020 de la Agencia Española de Medicamentos y Productos Sanitarios, relativa a [...]
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial [...]
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.). The CHMP’s decision to start the rolling review of mRNA-1273 is based on preliminary results from non-clinical studies and early clinical studies in adults [...]
EMA has recommended granting a marketing authorisation in the European Union for the gene therapy Libmeldy to treat metachromatic leukodystrophy (MLD), a rare inherited metabolic disease that affects the nervous system. Libmeldy is indicated for use in children with the ‘late infantile’ or ‘early juvenile’ forms of MLD, who have been identified as carriers of the defective [...]