Policy for supply of unlicensed medicinal product for the treatment
- Patient has a serious or life-threatening disease and no alternative treatments are available.
- Patient's condition is not eligible to enroll in a clinical trial sponsored by Shionogi.
- The patient’s physician determines the patient could potentially benefit from access to the unlicensed medicinal product before it is approved by a regulatory agency.
The request directed to Shionogi must be in writing, must be signed and submitted by a licensed physician who is in a treatment relationship with the patient for whom the unlicensed medicinal product is being requested. Shionogi does not guarantee it can or will approve access to such unlicensed medicinal products pursuant to the request as it has to evaluate several factors such as the total amount of available unlicensed medicinal products stocked. Shionogi may require up to five (5) business days to acknowledge and/or review the request.
Contact information for physician: