FDA批准PRIORIX疫苗说明书补充修订，新增免疫抑制治疗禁忌信息
美国食品药品管理局（FDA）于2025年11月14日向葛兰素史克生物制品公司（GlaxoSmithKline Biologicals SA）发出补充批准函，批准麻疹、腮腺炎和风疹活疫苗PRIORIX的生物制品许可申请补充修订，文号为STN BL 125748/119。该补充申请由FDA于2025年5月15日收到。
本次修订涉及PRIORIX的包装说明书与纸盒标签。说明书第4.2节禁忌与第7.1节药物相互作用新增与免疫抑制治疗有关的信息；第6.2节不良反应新增活检检出风疹疫苗病毒的慢性皮肤肉芽肿条目；第8.1节特定人群使用新增一例先天性风疹综合征条目，另有若干小的标签修改。
FDA在批准函中要求，申办方须在函件日期起14天内通过FDA自动药品注册与列名系统以结构化产品标签格式提交最终标签内容。PRIORIX是一款麻疹、腮腺炎和风疹活疫苗，本次批准属于说明书信息更新，不涉及新的适应症。
FDA Approves PRIORIX Labeling Supplement on November 14, Adding Immunosuppressive-Treatment Contraindication Information
On November 14, 2025, the U.S. Food and Drug Administration (FDA) issued a supplement approval letter to GlaxoSmithKline Biologicals SA for PRIORIX, a measles, mumps, and rubella vaccine, live, under Biologics License Application STN BL 125748/119. The FDA had received the supplement request on May 15, 2025.
The revision covers the PRIORIX package insert and carton label. It adds immunosuppressive-treatment-related information to Contraindications (Section 4.2) and Drug Interactions (Section 7.1), adds chronic cutaneous granulomas with rubella vaccine virus detected by biopsy to Adverse Reactions (Section 6.2), and adds a case of congenital rubella syndrome to Use in Specific Populations (Section 8.1), along with minor associated labeling changes.
In the approval letter, the FDA directed the company to submit the final content of labeling in Structured Product Labeling format through the FDA automated drug registration and listing system as soon as possible, and no later than 14 days from the date of the letter. The approval is a labeling update and does not add a new indication.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：PRIORIX麻疹、腮腺炎和风疹活疫苗产品包装与药瓶。照片：Dctrzl，CC BY-SA 4.0，经 Wikimedia Commons / PRIORIX measles, mumps and rubella vaccine packaging and vial. Photo: Dctrzl, CC BY-SA 4.0, via Wikimedia Commons
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