Today, the U.S. Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). These tests look for signs of genetic abnormalities in a fetus by testing a sample [...]
mRNA COVID-19 vaccines: PRAC finds no link with autoimmune hepatitis The PRAC has concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis (AIH). AIH is a serious chronic inflammatory condition in which the immune system attacks and damages the liver. Signs and symptoms of autoimmune [...]
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.Este boletín incluye la nueva información de seguridad derivada de la evaluación de los datos de farmacovigilancia de medicamentos de uso humano [...]
Today, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). The IGA results in the equivalent genotype (genetic make-up) and [...]
On 11 February 2022, EMA’s safety committee, PRAC, recommended that the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss. The safety of HES solutions for infusion was reviewed in two separate procedures in [...]
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6 to 11. The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 and above. The dose of Spikevax in children from 6 to 11 years of age [...]
La Agencia ha ordenado estas medidas debido a que el esmalte endurecedor para uñas comercializado por las empresas Cosméticos Foráneos, S.L., y Cibitra 2001, S.L contiene formaldehído Esta sustancia está prohibida desde 2019 en los productos cosméticos Se informa a las personas usuarias de que no se debe utilizar este producto En el marco de [...]
Today, the U.S. Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. All of the cases are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, Michigan facility. As a result of the ongoing investigation, along with the U.S. Centers for Disease Control and Prevention and state and [...]
EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis). The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The [...]
EMA’s safety committee, PRAC, has recommended that the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss. The safety of HES solutions for infusion was reviewed in two separate procedures in 2013, and a [...]
EMA is initiating today the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®). The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, [...]
EMA has started evaluating an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer’s vaccine) in adolescents aged 12 to 15 years. An application in older adolescents aged 16 to 17 years is also ongoing. Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it [...]
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 [...]
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.A título informativo el Comité de Medicamentos de Uso Humano (CMH) de la AEMPS reunido por teleconferencia el día 18 de enero [...]
As we have throughout the COVID-19 pandemic, the U.S. Food and Drug Administration has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is [...]
Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue to spread in EU/EEA countries. EMA’s COVID-19 task force (ETF) highlights the growing evidence indicating that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. The task force undertook a detailed review of several [...]
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 Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) inició en enero de 2021 una campaña de control del mercado de dispositivos [...]
Review of terlipressin medicines started EMA has started a review of medicines that contain terlipressin. These medicines are authorised in several EU countries to treat increased pressure in central veins causing kidney problems in people with advanced liver disease (hepatorenal syndrome; HRS), as well as bleeding from enlarged veins in the passage between the mouth [...]
EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused by the Omicron variant which is now spreading rapidly across the EU. Although Omicron appears to be more infectious than other variants, studies from South Africa, UK and some EU countries show a lower risk of being hospitalised after [...]
A Agência Europeia de Medicamentos (EMA na sigla em inglês) continua a monitorizar os dados sobre a eficácia das vacinas contra a COVID-19, incluindo a doença causada pela variante Omicron. Embora a variante Omicron pareça ser mais infeciosa do que outras variantes, os estudos realizados em alguns países, nomeadamente, África do Sul, Reino Unido e [...]