RYPLAZIM
STN: 125659
Proper Name: plasminogen, human-tvmh
Tradename: RYPLAZIM
Manufacturer: Prometic Biotherapeutics Inc.
Indication:
- For the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia)
Product Information
- Package Insert - RYPLAZIM
- Demographic Subgroup Information – plasminogen, human-tvmh
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- May 12, 2022 Approval Letter - RYPLAZIM
- June 4, 2021 Approval Letter - RYPLAZIM
- June 4, 2021 Summary Basis for Regulatory Action - RYPLAZIM
- Approval History, Letters, Reviews, and Related Documents - RYPLAZIM