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EU drug regulator endorses changes to remdesivir marketing for COVID-19 use

New terms add that a patient can need ‘low- or high-flow oxygen or other non-invasive ventilation at start of treatment’
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Bengaluru, December 11

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Europe’s medicines regulator on Friday recommended adopting changes to the terms of the conditional approval for Gilead’s remdesivir as a COVID-19 treatment in Europe, to make clear the conditions under which it can be used.

The new terms add that a patient could need “low- or high-flow oxygen or other non-invasive ventilation at start of treatment”, the agency said.

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It is already indicated for use in patients aged 12 years and older with body weight at least 40 kg, and having pneumonia with a need for breathing support. Reuters

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