Home » Biopure Submits Response for Hemopure
Biopure Submits Response for Hemopure
Biopure has submitted a complete response to the provisional opinion letter issued by the UK Commission on Human Medicines (CHM) regarding the company’s application for Hemopure.
The requested indication is for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age when blood is not readily available or not an option.
The company submitted its application in July 2006 and received a provisional opinion letter in December 2006, which contained CHM’s questions and requests for additional analyses, Biopure said.
Biopure met with the Medicines and Healthcare products Regulatory Agency in September to review and finalize its responses.
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