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(Cas) AEMPS: El CHMP concluye que la dexametasona es una alternativa eficaz para el tratamiento de la COVID-19

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 España, dexametasona se ha estado utilizado para tratamiento de la COVID-19 en el contexto de la práctica clínica habitual y [...]

2020-09-27T11:09:08+00:0027.09.2020|Pharmacovigilance, Regulatory Affairs|

(Cas) La AEMPS actualiza la información para los Titulares de Autorizaciones de Comercialización de medicamentos de uso humano, autorizados por procedimiento nacional (incluyendo PRM/PDC) en relación con el art. 5(3) del Reglamento (CE) N° 726/2004

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. Con fecha 06 de agosto de 2020, la Agencia Europea de Medicamentos (en adelante, EMA) y el Grupo Europeo de Coordinación [...]

2020-09-25T13:23:15+00:0025.09.2020|Quality System and Audit, Regulatory Affairs|

ANSM: Avis et recommandations du Comité des médicaments pédiatriques (PDCO) de l’Agence européenne des médicaments (EMA)

Ce Comité est chargé notamment de l’évaluation des PIPs (Plans d’Investigations Pédiatriques) qui encadrent les programmes de développement en qualité préclinique et clinique des médicaments destinés à la population pédiatrique (de la naissance à 17 ans inclus), ainsi que des dérogations et reports de développement en pédi1atrie. Le PDCO vérifie la réalisation du programme d’études [...]

2020-09-25T12:45:54+00:0025.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020

Seven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting. The CHMP adopted a positive opinion for Exparel (bupivacaine), for the treatment of post-operative pain. The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria [...]

EMA: New oral treatment for moderate to severe atopic dermatitis

EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Olumiant is already approved in the European Union to treat moderate to severe active rheumatoid arthritis, a disease causing inflammation of the joints. Atopic dermatitis (also known [...]

2020-09-25T09:30:45+00:0025.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

EMA’s human medicines committee (CHMP) has completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital, and has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical [...]

2020-09-24T15:21:41+00:0024.09.2020|Drug Development Strategy|

EMA: First treatment for rare metabolic disorder alkaptonuria

EMA has recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria in adult patients. This rare disorder affects one in every 250,000 to 1 million people and is more common in certain areas of Slovakia. It is characterised by the inability of the body to metabolize homogentisic acid (HGA) due to [...]

2020-09-24T15:17:10+00:0024.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA: New treatment for children with chronic kidney disease

EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood phosphate levels), which, [...]

2020-09-24T11:41:38+00:0024.09.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA: One pharmacist’s report helps safer use of inhalers in the UK

Reporting suspected side effects or incidents to the Yellow Card scheme supports the safe use of medical products for everyone After a patient nearly choked when accidentally inhaling their lung medication capsule through the wrong part of their inhaler – Jazz, a concerned pharmacist, alerted the Medicines and Healthcare products Regulatory Agency (MHRA) of the [...]

2020-09-24T11:31:41+00:0024.09.2020|Pharmacovigilance|

UK MHRA: Safety-critical alerts are changing at the MHRA

The MHRA will now issue all safety-critical alerts for medicines and medical devices that require action as National Patient Safety Alerts The Medicines and Healthcare products Regulatory Agency (MHRA) is changing the way it issues safety-critical alerts to healthcare providers. From now on, all safety-critical alerts for medicines and medical devices that require action to [...]

2020-09-24T11:26:53+00:0024.09.2020|Pharmacovigilance|

Infarmed: Nova edição do Boletim de Farmacovigilância, Volume 24, n.º 7, julho de 2020

Já está disponível a nova edição do Boletim de Farmacovogilância, Volume 24, nº 7 de julho de 2020. Publicação com informação sobre efeitos adversos de medicamentos autorizados, quer a nível nacional quer europeu. Encontra-se também, nesta publicação, informação detalhada sobre os Alertas de Segurança emitidos pelo Infarmed. Posted on the Infarmed website on 17 September 2020

2020-09-24T11:08:36+00:0024.09.2020|Pharmacovigilance|

ANSM: La production, la vente et l’achat de phénibut, un psychotrope de synthèse, sont désormais interdits

Le phénibut a été inscrit sur la liste des psychotropes par le Ministère des solidarités et de la santé, afin d’en interdire notamment la production, la vente ou cession, l’acquisition et l’emploi, compte tenu des risques graves pour la santé publique liés à la consommation de cette drogue de synthèse. Qu’est-ce que le phénibut? Le phénibut [...]

2020-09-22T20:41:08+00:0022.09.2020|Pharmacovigilance|

Infarmed: Aprovada lista dos grupos homogéneos e dos preços de referência unitários – 4.º trimestre de 2020

A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2020 foi aprovada. Consulte a área Sistema de Preços de Referência, na página Avaliação de Tecnologias de Saúde, nomeadamente a Circular Informativa N.º 148/CD/100.20.200, Data: 09/09/2020 e a Deliberação N.º 71/CD/2020. Posted on the Infarmed website on 17 September 2020

2020-09-22T20:45:25+00:0022.09.2020|Regulatory Affairs|

(Cas) AEMPS: España, escogida de nuevo para producir la vacuna contra la COVID-19

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 biotecnológica estadounidense Novavax anuncia que un grupo biofarmacéutico español llevará a cabo la producción industrial de su vacuna en España [...]

2020-09-22T20:34:54+00:0022.09.2020|Drug Development Strategy|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de julio de 2020

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 [...]

ANSM: Mise en garde sur l’utilisation potentiellement dangereuse de médicaments chez des enfants atteints d’autisme

Des prescriptions sur de longues durées (plusieurs mois), hors AMM, de médicaments anti-infectieux et de chélateurs de métaux lourds ont été identifiées chez des enfants atteints d’autisme. L’ANSM déconseille formellement ces utilisations pour lesquelles ces médicaments n’ont fait aucune preuve de leur efficacité et qui exposent ces enfants à des risques, en particulier lors d’une [...]

2020-09-17T22:26:22+00:0017.09.2020|Pharmacovigilance|

EMA: Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21

The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan  which sets actions to be delivered in 2020-21. With the European Medicines Regulatory Network focused on the response to the COVID-19 pandemic, the workplan aims to progress evolution to data-driven regulation through smart working, leveraging collaboration with stakeholders and the use [...]

2020-09-16T19:35:49+00:0016.09.2020|Drug Development Strategy, Regulatory Affairs|

ANSM: Lutényl/Lutéran et risque de méningiome: appel à participation en vue d’une consultation publique

Depuis  plusieurs années, nous avons engagé des mesures afin de limiter le risque de méningiome chez les femmes traitées par Lutényl (acétate de nomégestrol), Lutéran (acétate de chlormadinone) et leurs génériques. Dans le prolongement de ces actions, nous mettons en place une consultation publique sur l’utilisation actuelle de ces médicaments et sur les attentes des [...]

2020-09-16T19:30:54+00:0016.09.2020|Pharmacovigilance|

(Cas) AEMPS: Recomendaciones de actuación en la industria de producción y distribución farmacéutica ante casos de infección por COVID-19

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 industria es considerada esencial y debe asegurarse de que la estrategia de detección, vigilancia y control de COVID-19 no afecte [...]

2020-09-14T21:27:09+00:0014.09.2020|Regulatory Affairs|

FDA Warns Website Operators Illegally Selling Opioids to Consumers

The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use. The opioids offered [...]

2020-09-14T21:20:47+00:0014.09.2020|Pharmacovigilance, Regulatory Affairs|