Janssen&Janssen schreef op 9 april 2024 19:27:
How to safely get leniolisib before its MHRA and EMA approvals
Despite what the timelines above suggest, waiting is not the only option for APDS patients in Europe and the UK.
You could immediately access the medicine by importing it for your personal use. This option is known as Named Patient Import, or expanded access. Here's how it works.
Leniolisib expanded access
Even if a medicine is not yet approved or available in your country, you can legally access it. A regulation known as Named Patient Import allows you to buy and import a medicine, as long as it meets these conditions:
it is approved somewhere;
it is not approved or available in your country (yet);
it has no local alternatives, and
it is for personal use.
This process requires a prescription from your treating doctor. As in all other cases, the doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.
Do you want to start your treatment with leniolisib sooner, using the Named Patient Import regulation? You will first need to consult your treating doctor and get a suitable prescription.