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