CSL Limited Annual Report 2022/23 15 Product Registrations and Indications 2022/23* Immunology Focus and deliver enhanced patient convenience, plasma yield improvements, expanded labels and indications, new formulation science and recombinant therapies for underserved immune-mediated conditions Product Type Country/Region BERINERT® C1-Esterase Inhibitor (Human) Intravenous or Subcutaneous1 NR Japan (2000 IU); Qatar &United Arab Emirates (500, 2000, 3000 IU); Argentina (2000, 3000 IU) HIZENTRA® Immune Globulin Subcutaneous (Human) 20% Liquid NR Saudi Arabia, Qatar, United Arab Emirates, Oman HIZENTRA® Immune Globulin Subcutaneous (Human) 20% Liquid NI Switzerland, Russia (SID) Haematology Maximise the value and performance of our newand existing therapies and discover and develop new innovative therapies in benign (non-malignant) haematology AFSTYLA® Coagulation Factor VIII (Recombinant) NR Turkey (500, 1000, 2000 IU); Kuwait & Oman (250, 500, 1000, 2000, 3000 IU); Chile (250, 500, 1000, 1500, 2000, 3000 IU); Brunei (250, 500 IU) Albumin (human) 20% Behring, low salt NR Qatar, United Arab Emirates, Morocco ALBURX® Human Albumin NR Costa Rica, El Salvador, Guatemala, Trinidad and Tobago BERIPLAST® P Combi-Set Human thrombin, Aprotinin, Human Fibrinogen, Calcium chloride NR Singapore BERIPLEX® Prothrombin Complex (Human) NR Trinidad and Tobago HAEMATE® Coagulation Factor VIII/vWF (Human) NR Saudi Arabia (250, 500 IU); United Arab Emirates, Bulgaria & Algeria (250, 500, 1000 IU) HAEMOCOMPLETTAN® P Fibrinogen Concentrate (Human) NR United Arab Emirates, Malaysia, Morocco, Oman HEMGENIX® Etranacogene dezaparvovec NR United States, European Union, Great Britain IDELVION® Coagulation Factor IX (Recombinant) Albumin Fusion Protein NR New Zealand (3500 IU), Turkey (250, 500, 1000, 2000 IU); Kuwait (250, 500, 1000, 2000, 3000 IU) IDELVION® Coagulation Factor IX (Recombinant) Albumin Fusion Protein NI European Union, Great Britain & Switzerland (PUP); South Korea (21d dosing) Vaccines Develop products for the prevention of infectious diseases FLUAD® QUADRIVALENT2 Influenza Vaccine, Adjuvanted (surface antigen, inactivated) NR Taiwan, Brazil, South Korea (for the prevention of influenza in persons aged 65 yrs and older) CSL Vifor Focus and deliver products for the treatment of iron deficiency, dialysis, nephrology & rare disease FERINJECT® Ferric carboxymaltose NR China FERINJECT® Ferric carboxymaltose NI European Union, Great Britain (for the treatment of iron deficiency in patients aged 1-13 years) INJECTAFER® Ferric carboxymaltose NI United States (for the treatment of iron deficiency in patients with heart failure) KORSUVA® Difelikefalin3,4 NR Switzerland, Canada, Australia, Singapore, United Arab Emirates, Kuwait, Israel TAVNEOS® Avacopan5 NR Australia, Switzerland, United Arab Emirates, Kuwait VELPHORO® Sucroferric oxyhydroxide NR China, Thailand VELTASSA® Patiromer sorbitex calcium NR Russia * First-time registrations or registered indications for CSL products in the listed countries/regions over the reporting period. 1 In some markets, subcutaneous version of C1-esterase inhibitor is marketed as HAEGARDA®. 2 In some markets, FLUAD® QUADRIVALENT is marketed as FLUAD® QUAD and FLUAD® TETRA. 3 In some markets, KORSUVA® is marketed as KAPRUVIA®. 4KORSUVA®/KAPRUVIA® is a registered trademark of Cara Therapeutics, Inc. 5 TAVNEOS® is a registered trademark of ChemoCentryx, Inc. IU = International Unit, NI = New Indication, NR = New Registration, PUP = Previously Untreated Patients, SID = Secondary Immunodeficiency.
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