IDELVION albutrepenonacog alfa 3500 IU powder (and diluent) for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Factor IX, Quantity: 3500 IU

Available from:

CSL Behring Australia Pty Ltd

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

3500 IU

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

IDELVION is indicated in all patients with haemophilia B for:,? Routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? Control and prevention of bleeding episodes,? Control and prevention of bleeding in the perioperative setting.

Product summary:

Visual Identification: Clear solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store between 2 - 25 degrees celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-11-19