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(Cas) AEMPS: Actualización de la información sobre retirada de lotes de Omeprazol Farma-Química Sur S.L. que contenían minoxidil y seguimiento clínico de los niños expuestos

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 los análisis llevados a cabo por la AEMPS, se han identificado dos lotes que contenían minoxidil en lugar de omeprazol [...]

2019-09-19T20:17:37+00:0019.09.2019|Pharmacovigilance|

Infarmed: Aprovada lista dos grupos homogéneos e dos preços de referência unitários – 4.º trimestre de 2019

A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2019 foi aprovada. Consulte a área Sistema de Preços de Referência, na página Avaliação de Tecnologias de Saúde, nomeadamente a Circular Informativa N.º 140/CD/100.20.200, de 12/09/2019 e a Deliberação N.º 76/CD/2019. Posted on the Infarmed website on 17 September 2019

2019-09-19T20:49:58+00:0019.09.2019|Regulatory Affairs|

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two [...]

2019-09-19T20:04:29+00:0019.09.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Revisión de los medicamentos que contienen ranitidina por la presencia de nitrosaminas

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 AEMPS informa del inicio de dos procedimientos europeos en relación a la presencia de nitrosaminas en medicamentos de uso humano. [...]

2019-09-18T20:37:14+00:0018.09.2019|Pharmacovigilance|

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]

EMA to review ranitidine medicines following detection of NDMA

At the request of the European Commission, EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies. It is present in some [...]

2019-09-16T20:30:15+00:0016.09.2019|Pharmacovigilance|

Infarmed: Suspensão de atividades do distribuidor por grosso Nvn Iapharm Pharmaceuticals Ldt (Chipre)

A autorização de distribuição por grosso de medicamentos da entidade NVN IAPHARM PHARMACEUTICALS LDT foi suspensa após a deteção de não conformidades com as Boas Práticas de Distribuição, conforme divulgado pela Agência do Medicamento do Chipre. O relatório destas não conformidades pode ser consultado na base de dados de acesso público EudraGMDP, estando a suspensão [...]

2019-09-16T19:32:08+00:0016.09.2019|Regulatory Affairs|

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a [...]

2019-09-13T21:35:34+00:0013.09.2019|Pharmacovigilance|

(Cas) AEMPS: Ondansetrón: riesgo de defectos de cierre orofaciales (labio leporino, paladar hendido) tras su uso durante el primer trimestre del embarazo

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. Existe un ligero aumento del riesgo de defectos de cierre orofaciales en hijos de madres expuestas a ondansetrón durante el primer [...]

2019-09-13T20:13:02+00:0013.09.2019|Pharmacovigilance|

ANSM: Lucentis® (ranibizumab): recommandations en cas de difficulté pour actionner le piston des seringues pré-remplies

Information destinée aux ophtalmologistes et aux pharmaciens Suite à des difficultés à actionner le piston de certaines seringues pré-remplies de Lucentis, il est recommandé aux professionnels de santé de: Vérifier systématiquement que le piston de la seringue pré-remplie puisse être poussé facilement lors de l’ajustement de la dose Ne pas commencer l’injection si le piston [...]

2019-09-13T20:08:07+00:0013.09.2019|Pharmacovigilance|

FDA Statement on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have [...]

2019-09-12T21:50:02+00:0012.09.2019|Pharmacovigilance, Regulatory Affairs|

Infarmed: Disponibilidade do medicamento: regulamento em consulta pública

O Decreto-lei n.º 112/2019, recentemente publicado, reforça o dever geral de serviço público de fornecimento e dispensa de medicamentos e as obrigações de todos os intervenientes da cadeia do medicamento, atendendo ao princípio basilar de que a salvaguarda do acesso ao medicamento é um dever do Estado, bem como de todos aqueles que intervêm no [...]

2019-09-12T20:30:50+00:0012.09.2019|Regulatory Affairs|

FDA approves first treatment for patients with rare type of lung disease

The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. “Patients suffering from scleroderma need effective therapies, and the FDA [...]

2019-09-12T20:21:43+00:0012.09.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019

PRAC starts review of data on skin cancer with Picato EMA’s safety committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. The review was triggered by data from several studies showing a [...]

2019-09-12T20:13:07+00:0012.09.2019|Sin categoría|

Infarmed: Nova edição do Boletim de Farmacovigilância, Volume 23, nº 7, julho de 2019

Já está disponível a nova edição do Boletim de Farmacovigilância, Volume 23, n.º 7 de julho de 2019. 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 4 September 2019

2019-09-11T12:50:09+00:0011.09.2019|Pharmacovigilance|

ANSM: Nutrition parentérale: les produits doivent être protégés de la lumière pour réduire les risques d’effets indésirables graves chez les nouveau-nés prématurés

Durant leur administration à des nouveau-nés et à des enfants de moins de 2 ans, les produits de nutrition parentérale contenant des acides aminés et/ou des lipides doivent être protégés de la lumière (conditionnements et dispositifs d’administration). L’utilisation de produits de nutrition parentérale contenant des acides aminés et/ou des lipides exposés à la lumière, particulièrement [...]

2019-09-11T11:11:52+00:0011.09.2019|Pharmacovigilance|

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, [...]

2019-09-11T11:07:36+00:0011.09.2019|Pharmacovigilance, Regulatory Affairs|

ANSM: GILENYA® (fingolimod) – Nouvelle contre-indication chez la femme enceinte et en âge de procréer n’utilisant pas une contraception efficace

Information destinée aux neurologues, neuro-pédiatres, gynécologues, obstétriciens, médecins généralistes et pharmaciens En raison du risque de malformations congénitales chez le fœtus exposé au fingolimod (Gilenya ®), le fingolimod est à présent contre-indiqué chez: la femme enceinte, la femme en âge de procréer n’utilisant pas une contraception efficace. Les données rapportées chez l’homme après la commercialisation suggèrent que [...]

2019-09-10T21:14:13+00:0010.09.2019|Pharmacovigilance|

ANSM: Surdosage et overdose d’opioïdes: point sur l’offre thérapeutique de la naloxone en France

A l’occasion de l’Overdose Awareness Day ce samedi 31 août, l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) réalise un point de situation sur l’offre thérapeutique des antidotes aux opioïdes en France. L’ANSM a octroyé deux autorisations de mise sur le marché (AMM) pour des kits de naloxone prête à l’emploi: [...]

2019-09-10T20:23:47+00:0010.09.2019|Drug Development Strategy, Regulatory Affairs|

UK MHRA: HRT users to discuss risks and benefits at next appointment as new study highlights persistent risk of breast cancer

Women who are current or past users of hormone replacement therapy (HRT) to treat symptoms of the menopause are reminded to be vigilant for signs of breast cancer, even after stopping HRT. This is because a new study, published by The Lancet, has confirmed that women who use HRT for longer than 1 year have a [...]

2019-09-10T19:59:01+00:0010.09.2019|Pharmacovigilance|