STN: 125062
Proper Name: Immune Globulin Intravenous (Human)
Tradename: OCTAGAM
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Indication:

Indicated for the treatment of:

• Extension of the shelf life of Octagam 5% from 24 months to 36 months at +2°C (36°F) to +8°C (46°F).

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