PANZYGA (Octapharma Australia Pty Ltd)
Product name
PANZYGA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
212 working days (255)
Active ingredients
human immunoglobulin G
Registration type
NCE/NBE
Indication
PANZYGA (solution for intravenous infusion) is indicated for:
Replacement therapy in:
- Primary immunodeficiency diseases
- Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent bacterial infections
- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment
Immunomodulation in:
- Idiopathic thrombocytopenic purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count
- Guillain Barré syndrome
- Kawasaki disease