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6-K: Gsk's Shingrix New Prefilled Syringe Presentation Accepted for Review by European Medicines Agency

6-K: Gsk's Shingrix New Prefilled Syringe Presentation Accepted for Review by European Medicines Agency

6-K:葛蘭素史克Shingrix新型預充式注射器產品獲得歐洲藥品管理局審核
美股SEC公告 ·  01/27 12:29

牛牛AI助理已提取核心訊息

GSK announced that the European Medicines Agency has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix vaccine for shingles prevention. The new presentation eliminates the need to reconstitute separate vials before administration, offering healthcare professionals a more convenient option. This follows the US FDA's acceptance of the file on January 8, 2025.The vaccine maintains identical composition to the current version, which consists of a lyophilised antigen and liquid adjuvant. Shingrix has been approved in the EU since 2018 for adults aged 50 and older, and since 2020 for adults 18 and older at increased risk of herpes zoster. Over 25 million Europeans have received the vaccine since its launch.Shingles, affecting up to 1 in 3 adults in their lifetime, typically presents as a painful rash and can lead to post-herpetic neuralgia in up to 30% of cases. The condition significantly impacts work productivity, with 57% of affected individuals missing an average of 9.1 workdays.
GSK announced that the European Medicines Agency has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix vaccine for shingles prevention. The new presentation eliminates the need to reconstitute separate vials before administration, offering healthcare professionals a more convenient option. This follows the US FDA's acceptance of the file on January 8, 2025.The vaccine maintains identical composition to the current version, which consists of a lyophilised antigen and liquid adjuvant. Shingrix has been approved in the EU since 2018 for adults aged 50 and older, and since 2020 for adults 18 and older at increased risk of herpes zoster. Over 25 million Europeans have received the vaccine since its launch.Shingles, affecting up to 1 in 3 adults in their lifetime, typically presents as a painful rash and can lead to post-herpetic neuralgia in up to 30% of cases. The condition significantly impacts work productivity, with 57% of affected individuals missing an average of 9.1 workdays.
GSK宣佈,歐洲藥品管理局已接受對Shingrix生物-疫苗的監管申請,該申請涉及預裝注射器形式以預防帶狀皰疹。這種新形式不需要在給藥前重新配製分開的瓶子,爲醫療專業人員提供了更方便的選擇。這是在2025年1月8日美國FDA接受該文件之後的進展。該生物-疫苗的成分與當前版本相同,仍由凍幹抗原和液體佐劑組成。自2018年以來,Shingrix在歐盟獲批用於50歲及以上的成年人,2020年以來,也獲批用於增加帶狀皰疹風險的18歲及以上成年人。自推出以來,已有超過2500萬歐洲人接種了該生物-疫苗。帶狀皰疹影響着三分之一的成年人,通常表現爲疼痛性皮疹,並且在多達30%的病例中可能導致帶狀皰疹後神經痛。該控制項顯著影響工作生產力,57%的受影響個體平均缺勤9.1天。
GSK宣佈,歐洲藥品管理局已接受對Shingrix生物-疫苗的監管申請,該申請涉及預裝注射器形式以預防帶狀皰疹。這種新形式不需要在給藥前重新配製分開的瓶子,爲醫療專業人員提供了更方便的選擇。這是在2025年1月8日美國FDA接受該文件之後的進展。該生物-疫苗的成分與當前版本相同,仍由凍幹抗原和液體佐劑組成。自2018年以來,Shingrix在歐盟獲批用於50歲及以上的成年人,2020年以來,也獲批用於增加帶狀皰疹風險的18歲及以上成年人。自推出以來,已有超過2500萬歐洲人接種了該生物-疫苗。帶狀皰疹影響着三分之一的成年人,通常表現爲疼痛性皮疹,並且在多達30%的病例中可能導致帶狀皰疹後神經痛。該控制項顯著影響工作生產力,57%的受影響個體平均缺勤9.1天。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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