Product Registration and Indications 2023/24* Product Type Country/Region Immunology Focus on improved patient convenience, plasma yield improvements, expanded labels, new formulation science and recombinant technology BERINERT® C1 Esterase Inhibitor (Human) Intravenous1 NR Algeria (500, 1500 IU); Saudi Arabia (500, 2000, 3000 IU) BERIRAB® Human Rabies Immunoglobulin NR Iraq, Kuwait HAEGARDA® C1 Esterase Inhibitor (Human) Subcutaneous NR Saudi Arabia (2000, 3000 IU) HEPATITIS B Immunoglobulin P Behring NR Kuwait (200, 1000 IU) HIZENTRA® Immune Globulin Subcutaneous (Human) 20% Liquid NR Kuwait HIZENTRA® Immune Globulin Subcutaneous (Human) 20% Liquid NI Bosnia & Herzegovina (CIDP, SID); Belarus, Ecuador, Peru, Qatar, United Arab Emirates (SID) PRIVIGEN® Immune Globulin Intravenous (Human) 10% Liquid NR South Africa TETAGAM® Human Tetanus Immunoglobulin NR Iraq Haematology Maximise the value and performance of CSL’s existing coagulation therapies and develop new protein and gene-based therapies AFSTYLA® Coagulation Factor VIII (Recombinant) NR Colombia (500, 1000, 2000 IU); Egypt (250, 500, 1000 IU); Serbia (500, 1000, 2000 IU) BERIPLEX® Prothrombin Complex (Human) NR Colombia HAEMATE® Coagulation Factor VIII/vWF (Human) NR Kuwait, Ukraine (250, 500, 1000 IU); Qatar (500, 1200 IU) HAEMOCOMPLETTAN® P Fibrinogen Concentrate (Human) NR Algeria HEMGENIX® Etranacogene dezaparvovec NR Australia; Canada; Switzerland IDELVION® Coagulation Factor IX (Recombinant) Albumin Fusion Protein NR Colombia, Uruguay (500 IU); Mexico (3500 IU); Qatar (250, 500, 1000 IU); Serbia (500, 1000, 2000 IU); Oman, Saudi Arabia (250, 500, 1000, 2000, 3500 IU) Nephrology and Transplant Develop therapies to preserve kidney function in rare renal diseases and to address transplant rejection and patient survival for both solid organ and haematopoietic stem cell transplant recipients FILSPARI® (Sparsentan) Dual ET A & AT1 antagonist (IgAN) 2 NR European Union KORSUVA® KOR Agonist (CKD-aP)3 NR Saudi Arabia TAVNEOS® Oral C5a Receptor Inhibitor (AAV)4 NR Israel, Korea, Saudi Arabia, Qatar VELTASSA® Oral Potassium Binder (HK) NI European Union, Great Britain (for treatment of hyperkalaemia in adults and adolescents aged 12–17 yrs) Vaccines Develop products for the prevention of infectious disease CELLDEMIC® Influenza (H5N1 ) vaccine zoonotic monovalent, adjuvanted (inactivated, cell-based) NR European Union FLUAD® QUADRIVALENT Influenza vaccine, adjuvanted (surface antigen, inactivated, egg-based)5 NR Argentina FLUAD® QUADRIVALENT Influenza vaccine, adjuvanted (surface antigen, inactivated, egg-based)5 NI European Union (for prevention of influenza in persons aged 50 yrs of age and older) FLUCELVAX® QUADRIVALENT Influenza vaccine (surface antigen, inactivated, cell-based)6 NI Australia, Great Britain, New Zealand (for prevention of influenza in persons aged 6m+) FOCLIVIA® Influenza A (H5N1) pandemic vaccine, adjuvanted (egg-based) NR Argentina (for prevention of influenza in persons aged 6m+) FOCLIVIA® Influenza A (H5N1) pandemic vaccine, adjuvanted (egg-based) NI Great Britain, European Union (for prevention of influenza in persons aged 6m+) INCELLIPAN® Influenza pandemic vaccine monovalent, adjuvanted (inactivated, cell-based)7 NR European Union PANVAX® Influenza (H5N8) pre-pandemic vaccine zoonotic monovalent, adjuvanted (egg-based) NR Australia CSL Vifor Focus and deliver products for the treatment of iron deficiency FERINJECT® (ferric carboxymaltose) NR Canada, Switzerland, Egypt FERINJECT® (ferric carboxymaltose) NI Australia (for treatment of iron deficiency anaemia in children aged 1–13 yrs); China (for treatment of iron deficiency in patients aged 1–17 yrs) * First-time registrations or 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. FILSPARI® licensed from Travere Therapeutics. 3. In some markets, KORSUVA® is marketed as KAPRUVIA®. KORSUVA®/KAPRUVIA® is a registered trademark of Cara Therapeutics, Inc. 4. TAVNEOS® is a registered trademark of ChemoCentryx Inc. 5. In some markets, FLUAD® QUADRIVALENT is marketed as FLUXVIR® QUAD, FLUAD® QIV, FLUAD® QUAD and FLUAD® TETRA. 6. In some markets, FLUCELVAX® QUADRIVALENT is marketed as FLUCELVAX® QIV, FLUCELVAX® QUAD and FLUCELVAX® TETRA. 7. In some markets, Incellipan® is marketed as AUDENZ®. AAV – Antineutrophilic cytoplasmic antibody (ANCA) associated vasculitis, AT – Angiotensin, CKD-aP – Chronic Kidney Disease associated Pruritus, CIDP – Chronic Inflammatory Demyelinating Polyneuropathy, ET – Endothelin, IgAN – Immunoglobulin A Neuropathy, HK – Hyperkalaemia, IU – International Unit, NI – New Indication, NR – New Registration, SID – Secondary Immunodeficiency, vWF – von Willebrand Factor 25
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