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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 27 November 2020

EMA’s safety committee (PRAC) has recommended updating product information for all chloroquine or hydroxychloroquine-containing medicines following a review that confirmed a link between the use of...

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Medicines Current Awareness (Remove filter)

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Safety Alerts (Add filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 16 November 2020

CHMP endorsed PRAC’s assessment of risk of liver injury but considered benefits of ulipristal in controlling fibroids may outweigh risk. It therefore recommends ulipristal remains available to treat...

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Medicines Current Awareness (Remove filter)

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Safety Alerts (Add filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 13 November 2020

The main change concerns the limits for nitrosamines, which will now apply to the finished products (e.g. tablets). These limits, should ensure that excess risk of cancer from nitrosamines in any...

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Medicines Current Awareness (Remove filter)

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Safety Alerts (Add filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 23 December 2020

The public meeting, to be held on 8 Jan, will be an opportunity to inform citizens about the approval and use of the new vaccines, to explain how the safety of the vaccines will be assured.

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Medicines Current Awareness (Remove filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 21 December 2020

EMA’s scientific opinion paves the way for first marketing authorisation of a COVID-19 vaccine in EU by European Commission with all the safeguards, controls and obligations this entails.

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Medicines Current Awareness (Remove filter)

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King's Fund (Remove filter)

Published by King's Fund, 28 October 2020

This briefing describes processes that decide whether NHS services in England will pay for patients to receive new, patented drugs, from the initial development & testing of drugs, to NICE’s...

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Medicines Current Awareness (Remove filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 30 October 2020

EMA’s safety committee (PRAC) has reviewed guidance developed by EMA for pharmaceutical companies on how to prepare risk management plans for COVID-19 vaccines. Guidance will now be sent for adoption...

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Medicines Current Awareness (Remove filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 11 December 2020

The licence extension as monotherapy, is for first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following...

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Medicines Current Awareness (Remove filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 11 December 2020

Tucatinib is an oral antineoplastic protein kinase inhibitor of HER2 kinase. Its benefits include increased progression free survival and overall survival including in patients with metastases.

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Medicines Current Awareness (Remove filter)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 11 December 2020

Available as prolonged-release granules, Sibnayal is an alkalising agent and buffer in metabolic acidosis. It is reported to correct metabolic acidosis in patients with distal renal tubular acidosis.

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Medicines Current Awareness (Remove filter)