ADYNOVATE

STN: BL 125566
Proper Name: Antihemophilic Factor, Recombinant, PEGylated
Tradename: ADYNOVATE
Manufacturer: Takeda Pharmaceuticals U.S.A., Inc.
Indication:

Indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use

Product Information

• Package Insert - ADYNOVATE
• Package Insert - ADYNOVATE (with external housing)

Supporting Documents

• August 9, 2023 Approval Letter - ADYNOVATE
• Statistical Review - ADYNOVATE
• Clinical Review Memo - ADYNOVATE
• June 14, 2021 Approval Letter - ADYNOVATE
• December 19, 2016 Clinical Review - ADYNOVATE
• October 28, 2016 Statistical Review - ADYNOVATE
• November 9, 2015 Clinical Review - ADYNOVATE
• October 1, 2015 Statistical Review - ADYNOVATE
• Supporting Documents older than three years - ADYNOVATE
• Approval History, Letters, Reviews, and Related Documents - ADYNOVATE