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 has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. In 2020, EMA recommended 97 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union before. The Agency recommended one vaccine and one treatment for COVID-19, and [...]
The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and [...]
EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines. ‘Healthcare professionals are the heroes of this pandemic,’ said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. ‘We [...]
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. Tras el abandono de Reino Unido de la UE, el período de transición también se ha dado por finalizado a 31 [...]
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 evaluación de los datos ya comenzó el pasado 1 de octubre a través del llamado rolling review, un mecanismo excepcional por el [...]
Dando continuidade ao projeto de Horizon Scanning iniciado em 2018, é com satisfação que o Infarmed comunica o lançamento de uma plataforma para recolha desta informação. Este projeto permitiu agregar informação relativa à introdução de novas tecnologias no Serviço Nacional de Saúde, viabilizando um melhor planeamento das atividades do Infarmed nesta área e contribuindo para a eficiência [...]
L’actualité mensuelle de l’agence nationale de sécurité du médicament et des produits de santé. Posted on ANSM website on 8 January 2021
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided [...]
The vaccine has been approved after meeting the required safety, quality and effectiveness standards. The COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on [...]
Dans un contexte européen de déploiement de la campagne de vaccination contre la Covid-19, plusieurs états se mobilisent pour accélérer l’accès aux vaccins, notamment pour les personnes les plus fragiles. C’est dans ce contexte que l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) donne un avis concernant la seconde dose du [...]
A Agência Europeia de Medicamentos (EMA, na sigla em inglês) recomendou a concessão de uma autorização de introdução no mercado condicional para a vacina do laboratório Moderna, para prevenir a doença COVID-19 em pessoas a partir dos 18 anos de idade. Esta é a segunda vacina COVID-19 que a EMA recomenda para autorização. Comunicado 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. Esta vacuna, desarrollada por Moderna, previene la enfermedad causada por SARS-CoV-2 en personas a partir de los 16 años El CHMP, [...]
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation. EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be [...]
Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the [...]
The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, [...]
EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. The Agency is currently assessing data on the vaccine as part of a rolling review. So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical [...]
O medicamento Pneumovax 23 (vacina pneumocócica poliosídica) obteve autorização de comparticipação na indicação: Imunização ativa contra a doença causada pelos serotipos pneumocócicos incluídos na vacina. A vacina é recomendada para indivíduos com idade igual ou superior a dois anos, nos quais existe um maior risco de morbilidade e mortalidade devido a doença pneumocócica. Os grupos [...]
Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of [...]
The new vaccine has been approved after meeting the required safety, quality and effectiveness standards. The COVID-19 vaccine developed by Oxford University/AstraZeneca has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) after meeting required safety, quality and effectiveness standards. Following a rigorous, detailed scientific review by the MHRA’s expert [...]