https://www.cancer.dk/hjaelp-viden/kraeftbehandling/ny-kraef..."Compassionate use
I særlige tilfælde kan en bestemt patient eller grupper af patienter få adgang til et ikke-godkendt lægemiddel. Dette kaldes compassionate use".
Human enkeltudlevering'
Hvis lægen mener, at et ikke-godkendt lægemiddel kunne gavne dig som patient, kan lægen ansøge lægemiddelfirmaet og lægemiddelstyrelsen om en såkaldt enkeltudleveringstilladelse.
EMEA
(
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.
NPP = Named Patient Program
Compassionate use should not be confused with ‘named-patient basis’ treatments, which see doctors obtain medicines directly from manufacturers before authorisation. This is done on an individual basis under the direct responsibility of the doctor, and the .....
eller:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5116859