Compassionate use permit for Remdesivir
The Danish Medicines Agency would like to inform you that it is possible to apply for a general compassionate use permit for Remdesivir for the treatment of COVID-19 patients who cannot be included in one of the protocol-based clinical trials that are currently being conducted in Denmark.
It is specialists in infectious medicine who can apply for a general compassionate use permit. As indicated in the EMA’s guidelines for ”Compassionate use of Remdesivir for COVID-19”, the medicine may be used to treat patients of 12 year of age weighing at least 40 kg who have tested positive for COVID-19 and require invasive mechanical ventilation.
There is only limited safety data available on the use of Remdesivir for treatment of COVID-19 positive patients. The Danish Medicines Agency reminds everyone who prescribes medicines under a compassionate use permit that they are subject to an enhanced information duty and a stricter duty to report all suspected adverse reactions.