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 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). [...]
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 [...]
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 [...]
The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU). This will pave the way for wider dissemination of the unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels. The product information (PI) of a medicine includes the package [...]
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 [...]
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, [...]
Today, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the health of all women, the Center for Devices and Radiological Health (CDRH) is sharing its Health of Women Program Strategic Plan. CDRH initially issued a proposed strategic plan in September 2019 and has considered public feedback to inform this [...]
International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against the COVID-19 Omicron variant, regulatory requirements for a variant vaccine and considerations on clinical study design. The workshop on the global response to the COVID-19 Omicron variant was organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and [...]
On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron variant during a workshop, co-chaired by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The goal of the meeting was to review available evidence for [...]
O medicamento Lutathera (Oxodotreótido de lutécio) obteve autorização para ser utilizado em meio hospitalar na indicação "Tratamento, em adultos, dos seguintes tumores neuroendócrinos (TNE) positivos para o recetor de somatostatina, bem diferenciados (G1 e G2), progressivos, não operáveis ou metastáticos: TNE gastrointestinais (jejuno-íleo e cólon proximal), em doentes elegíveis para tratamento com octreotido e com [...]
EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA EEIG. The application is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high [...]
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. “The country is in the middle [...]
O medicamento Talzenna (Talazoparib) obteve autorização para ser utilizado em meio hospitalar na indicação: "Talzenna em monoterapia é indicado no tratamento de doentes adultos com mutações germinativas BRCA1/2, que têm cancro da mama localmente avançado ou metastático e recetor do fator de crescimento epidérmico humano tipo 2 (HER2) negativo. Os doentes devem ter sido tratados [...]
Dans le contexte de la circulation active du variant Omicron, nous précisons aux professionnels de santé, en lien avec le ministère des Solidarités et de la Santé, l’activité connue à ce jour des traitements à base d’anticorps monoclonaux disponibles et leurs nouvelles conditions d’utilisation en curatif et en prophylaxie. Consulter le DGS-urgent Actuellement en France, [...]
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single booster dose to include use in individuals 12 through 15 years of age. Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster [...]
This new combination treatment is for people with mild to moderate COVID-19 who are at high risk of developing severe COVID-19 A COVID-19 treatment called Paxlovid (PF-07321332 and ritonavir) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of [...]