CSL New Zealand Rh(D) Immunoglobulin-VF (Human Anti-D Rho Immunoglobulin), 250 IU, solution for injection, vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
23-11-2017
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Active ingredient:
human immunoglobulin G, Quantity: 10 mg/mL; anti-D Rho immunoglobulin, Quantity: 250 IU
Available from:
CSL Behring Australia Pty Ltd
INN (International Name):
anti-D Rho immunoglobulin,human immunoglobulin G
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: glycine
Administration route:
Intramuscular
Units in package:
250 IU
Prescription type:
(S1) This Schedule is intentionally blank
Therapeutic indications:
Rh(D) Immunoglobulin-VF is indicated for the prevention of Rh sensitisation in Rh(D) negative females at or below child bearing age.
Product summary:
Visual Identification: Colourless, clear to opalescent solution; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Listed (Export Only)
Authorization date:
2011-05-05
