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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, 12 February 2021

The European Medicines Agency’s PRAC has assessed all available information and concluded there is currently no evidence indicating that reported kidney problems are associated with 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, 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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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)

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European Medicines Agency - EMA (Remove filter)

Published by European Medicines Agency, 11 December 2020

Fostemsavir is an oral antiviral that selectively inhibits the interaction between HIV and cellular CD4 receptors, thereby preventing viral entry into the host cells.

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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

Selpercatinib is a RET receptor tyrosine kinase inhibitor, inhibiting wild-type RET receptor tyrosine kinase and multiple mutated isoforms. Reported benefits include objective response rate and...

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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

Moxetumomab pasudotox is a CD22-targeted immunotoxin designed to direct the cytotoxic action of the truncated Pseudomonas exotoxin to cells which express the CD22 receptor. Reported benefits includes...

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Medicines Current Awareness (Remove filter)