Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 85

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 85
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%.                                                              ​   Used to re-establish and maintain circulation volume in the treatment of hypovolemia (i.e., traumatic or hemorrhagic shock, septic shock and severe burns) and to treat complications related to cirrhosis.                                                                                                                                                                                                                                                                                                                  
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Vistaseal™/VeraSeal®. Human fibrinogen/human thrombin.                                                                                                           ​   Used as a supplemental treatment in adults where standard surgical techniques are insufficient for improvement of haemostasis, and as suture support in vascular surgery.                                                                                                                                                                                                                                                                                                                                                    
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Tavlesse®. Fostamatinib Disodium Hexahydrate Film Coated Tablets.                                                                                                ​   Used for the treatment of chronic immune thrombocytopenia (“ITP”) in adult patients who are refractory to other treatments.                                                                                                                                                                                                                                                                                                                                                                                                  
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53

Intravenous immunoglobulin (IVIG) 
Gamunex-C® IVIG, a ready-to-use liquid IVIG product, is one of the leading products in the IVIG segment. We believe Gamunex-C® IVIG is one of the premium products in its category since its launch due to a comprehensive set of differentiated product characteristics. We are one of the market leaders in the production and marketing of immunoglobulin, with 24.3% market share in volume in the United States for the twelve-month period ended November 30, 2024, according to PPTA.
Subcutaneous Immunoglobulin (“SCIG”)
Xembify®, our 20% SCIG, was first launched in the United States in 2019, with the indication for treatment of primary immunodeficiencies. In 2024, the FDA approved a label expansion that allows patients who are IG treatment-naive to start SCIG therapy with Xembify® without having to first go through IVIG therapy, making Xembify® the first 20% SCIG product in the United States with such indication. This FDA approval also included new biweekly dosing (as opposed to the prior weekly dosage) enhancing flexibility and convenience for patients. Xembify® is also approved for use in both primary and secondary immunodeficiencies in Canada and several countries in the European Union. We launched Xembify® in ten countries in 2023 and 2024 (Spain and Australia in 2023, followed by Norway, Sweden, France, Czech