CSL Limited Annual Report 2021/22 36 Product Registrations and Indications 2021/22* Immunology Products Focus on improved patient convenience, plasma yield improvements, expanded labels, new formulation science and recombinant technology. Product Type Country/Region BERINERT® C1-Esterase Inhibitor (Human) Intravenous or Subcutaneous1 NR India, Taiwan, Netherlands, Ireland, Hong Kong, Lithuania, Estonia (500 IU); Netherlands, Ireland, Lithuania, Estonia (1500 IU); Russia, Netherlands, Ireland, Chile, Lithuania, Estonia (2000 IU& 3000 IU) PRIVIGEN® Immune Globulin Intravenous (Human) 10% Liquid NR Qatar, Brunei RHOPHYLAC® 300 Human anti-D (Rh0) immunoglobulin NR Hong Kong, Peru, Ecuador, Paraguay TETAGAM® Human Tetanus Immunoglobulin NR Netherlands, Belgium HIZENTRA® Immune Globulin Subcutaneous (Human) 20% Liquid NI European Union, Great Britain, Hong Kong, Macedonia (SID); Philippines, Hong Kong, Jordan (CIDP) PRIVIGEN® Immune Globulin Intravenous (Human) 10% Liquid NI Taiwan (MMN, MG, LEMS, SPS); Hong Kong (CIDP, SID) Haematology Products Maximise the value and performance of our existing coagulation therapies and develop newprotein and gene-based therapies. AFSTYLA® Coagulation Factor VIII (Recombinant) NR Saudi Arabia, United Arab Emirates, Qatar Albumin (human) 20% Behring, low salt NR Algeria ALBURX® Human Albumin NR Ukraine, Peru, Jamaica BERIATE® Coagulation Factor VIII (Human) NR Malaysia, Ecuador, Jamaica BERIPLAST® P Combi-Set NR India, Paraguay, Indonesia (3 mL) BERIPLEX® Prothrombin complex (Human) NR Paraguay HAEMATE® Coagulation Factor VIII/vWF (Human) NR Chile, Lithuania, Latvia, Estonia; Malaysia (1000 IU) HAEMOCOMPLETTAN® P Fibrinogen Concentrate (Human) NR India, Hong Kong IDELVION® Coagulation Factor IX (Recombinant) Albumin Fusion Protein NR Russia ALEVIATE® Coagulation Factor VIII/vWF (Human) NI Hong Kong (vWD prophylaxis) Vaccines Develop products for the prevention of infectious diseases. Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection PFS (unbranded duplicate of FLUAD® TETRA) NR Great Britain Cell-based Quadrivalent Influenza Vaccine (surface antigen, inactivated) Seqirus suspension for injection in PFS (unbranded duplicate of FLUCELVAX® TETRA) NR Great Britain FLUAD® QUAD Influenza Vaccine, Adjuvanted (surface antigen, inactivated) NR Argentina (for the prevention of influenza in persons 65 yrs of age and older) FLUCELVAX® QUADRIVALENT Influenza Vaccine (cell culture) NI United States (for the prevention of influenza in persons six months of age and older) FLUCELVAX® QUAD Influenza Vaccine (surface antigen, inactivated, cell culture) NI Canada, Argentina (for the prevention of influenza in persons six months of age and older) FLUCELVAX® QUAD Influenza Vaccine (surface antigen, inactivated, cell culture) NI Australia (for the prevention of influenza in persons two yrs of age and older) FLUCELVAX® QUAD Influenza Vaccine (surface antigen, inactivated, cell culture) NI New Zealand (for the prevention of influenza in persons nine yrs of age and older) In-LicensedProducts 2 RYALTRIS® (olopatadine hydrochloride &mometasone furoatemonohydrate) NI Australia (for the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in persons six yrs of age and older) * 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 can be marketed as HAEGARDA®. 2 RYALTRIS® is a registered trademark of Glenmark Pharmaceuticals Ltd. CIDP = Chronic Inflammatory Demyelinating Polyneuropathy, LEMS = Lambert-Eaton Myasthenic Syndrome, MG = Myasthenia Gravis, MMN = Multifocal Motor Neuropathy, NI = New Indication, NR = New Registration, PFS = Pre-Filled Syringe, SID = Secondary Immunodeficiency, SPS = Stiff Person Syndrome. 6 Powered by Innovation
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