[Gretchen Randlett]

Reply To: EAP – Label Requirements in CAN

Hello,
For a Named Patient Use request is Canada you absolutely can use English only label. You do not have to include French. In addition, you can divert material from an ongoing clinical trial to support the NPU request. Canada is extremely flexible in supporting compassionate use requests (aka Expanded Access Requests).
Cheers,
The GCSG Expanded Access Resource Team