EMA | News and press releases: EMA to launch new corporate website on 27 September 2018

Fresh design and improved features to provide better user experience

EMA | News and press releases: Companies stepping up efforts to ensure medicine supply post Brexit

Focus is now on 39 centrally authorised medicines, down from 108

FDA | FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

AEMPS | Retirada del complemento alimenticio NATUR CAP cápsulas

Retirada del complemento alimenticio NATUR CAP CÁPSULAS por contener los principios activos tadalafilo y sildenafilo, no declarados en su etiquetado.

EMA | News and press releases: New medicine to treat infections in adults

Vabomere, a combination of an antibiotic and new beta-lactamase inhibitor, addresses bacterial resistance

EMA | News and press releases: New medicine for the prevention of migraine

Monoclonal antibody Emgality recommended for marketing authorisation

EMA | News and press releases: Valsartan: review of impurities extended to other sartan medicines

A batch of losartan found to contain low levels of NDEA

EMA | News and press releases: New gene therapy for rare inherited disorder causing vision loss recommended for approval

Luxturna is the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene

AEMPS | Información a los laboratorios titulares de medicamentos de uso humano que contienen “mepivacaína”. Decisión de la Comisión C (2018) 5380 final, de fecha 2.08.2018 (Nº EMA: EMEA/H/A-30/1455)

La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informa de la publicación en su página web de la Decisión de Ejecución de la Comisión C (2018) 5380 final, de fecha 2 de agosto de 2018, en el marco del arbitraje por el artículo 30 de la Directiva 2001/83/CE, para los medicamentos de uso humano que contienen la sustancia activa “mepivacaína”.

EMA | News and press releases: Portugal to also benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 15 EU Member States and FDA

EMA | News and press releases: EMA’s Committee for Medicinal Products for Human Use (CHMP) elects new chair

Harald Enzmann to begin three-year mandate from 15 October 2018

FDA | Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

FDA | Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

FDA | Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids

Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids.

FDA | FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids

FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.

FDA | FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.

AEMPS | Nota Informativa de la reunión del Comité de Medicamentos de Uso Humano (CMH), celebrada el 11 de septiembre de 2018

A título informativo el Comité de Medicamentos de Uso Humano (CMH) reunido el día 11 de septiembre de 2018 ha informado favorablemente los siguientes productos, salvo error u omisión y sin que la siguiente relación tenga carácter definitivo ni vinculante.

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