OCTAGAM
STN: 125062
Proper Name: Immune Globulin Intravenous (Human)
Tradename: OCTAGAM
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Indication:
Indicated for the treatment of:
- Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI).
- Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of:
- Chronic immune thrombocytopenic purpura (ITP) in adults
- Dermatomyositis (DM) in adults
Product Information
- Package Insert - Octagam 5% Liquid Preparation
- Package Insert - Octagam 10% liquid solution for intravenous administration
Supporting Documents
- August 10, 2022 Approval Letter - Octagam 5%
- April 1, 2022 Approval Letter - Octagam 5% and 10%
- July 15, 2021 Approval Letter - Octagam
- Supporting Documents older than three years - Octagam