Compassionate use permit for Remdesivir

05 May 2020

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.

Link to application form for a general compassionate use permit at the Danish Medicines Agency’s website (in Danish only)

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.