EU drug regulator endorses adjustments to remdesivir advertising and marketing for COVID-19 use


Bengaluru, December 11

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.

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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