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 empresa L’Oreal que fabrica y comercializa los productos de la marca Vichy, de su división Cosmétique Active Internacional, ha comunicado a [...]
Update as of 25 May 2022: On 24 May 2022, the European Commission issued a legal decision confirming the suspension of the marketing authorisations of HES solutions for infusion. If necessary for public health reasons, individual EU Member States may delay the suspension for no longer than 18 months and keep HES solutions on the market, subject to agreed risk [...]
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 [...]
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 [...]
The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice of $13,320 to Sydney-based company Ferngrove Pharmaceuticals Pty Ltd (Ferngrove) for alleged contraventions of the Therapeutic Goods Act 1989 in relation to pharmacovigilance (activities monitoring the safety of medicines). The infringement notice relates to the alleged failure to provide information on [...]
General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 0.3% and 5.3% as of 1 April 2022, to reflect the inflation rate adjustments of 2020 and 2021 respectively. Full details of the new fee levels are available in Commission Regulation (EU) 2022/510 amending Council Regulation (EC) No 297/95, its implementing rules, and the corresponding explanatory note [...]
EMA, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), has launched the Cancer Medicines Forum (CMF). Bringing together representatives from academic organisations and the European medicines regulatory network, the forum aims at advancing research into optimising cancer treatments and will contribute to foster high standards in cancer care in the European Union (EU). [...]
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 took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health. What You Need to Know The FDA authorized several tobacco-flavored ENDS products from [...]
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation for Evusheld, developed by AstraZeneca AB, for the prevention of COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kg before potential exposure to the SARS-CoV-2 virus. Evusheld is made of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to attach [...]
At its 16-17 March meeting, EMA’s Management Bord elected Dr Lorraine Nolan as chair of the Board for a three-year period. Dr Nolan is the Chief Executive of the Irish Health Products Regulatory Authority (HPRA), a post she has held since January 2016. She has served as vice-chair of EMA’s Management board since October 2019 and as [...]
Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease [...]
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. Los problemas de suministro de medicamentos de impacto mayor, es decir, aquellos que causan un mayor trastorno a los pacientes, suponen [...]
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 [...]
The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of today, 1 March 2022. It puts some of the structures and processes established by EMA during the COVID-19 pandemic on a more permanent footing, while entrusting several new tasks to the Agency. EMA is now responsible for monitoring medicine shortages that might lead to [...]
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 [...]
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also approved to [...]
EMA’s human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents1 (as well as adults and children from 5 years of age) and a booster [...]
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 [...]