EN
登录

卫材和nippon medac Co., Ltd.宣布Metoject®甲氨蝶呤皮下注射笔作为自动注射器在日本获得监管批准

Metoject® Subcutaneous Injection Pen for Methotrexate Receives Regulatory Approval as Autoinjector in Japan

PHARMA FOCUS ASIA 等信源发布 2024-02-17 14:59

可切换为仅中文


Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito) and nippon medac Co., Ltd. (Headquarters: Tokyo, CEO: Hirohisa Iriyama), a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH (Headquarters: Germany), jointly announced today that they have received manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for an enhanced formulation of Metoject Subcutaneous Injection, an anti-rheumatic agent delivered via a pen-type autoinjector.

卫材株式会社(总部:东京,首席执行官:内藤春夫)和日本medac株式会社(总部:东京,首席执行官:Iriyama Hirohisa),medac Gesellschaft für klinische Spezialpräparate mbH(总部:德国)的子公司,今天联合宣布他们已获得日本厚生劳动省(MHLW)的制造和营销批准对于Metoject皮下注射的增强制剂,通过笔式自动注射器递送的抗风湿剂。

This formulation, titled 'Metoject® Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL, and 15mg Pen 0.30mL,' incorporates the previously approved Metoject Subcutaneous Injection pre-filled syringe into a more convenient pen-type autoinjector.The development of this formulation aims to alleviate the burden on patients and enhance safety during self-injection.

该制剂名为“Metoject®皮下注射7.5mg Pen 0.15mL,10mg Pen 0.20mL,12.5mg Pen 0.25mL和15mg Pen 0.30mL”,将先前批准的Metoject皮下注射预填充注射器整合到更方便的笔式自动注射器中。该制剂的开发旨在减轻患者的负担并提高自我注射期间的安全性。

The pen-type autoinjector allows for easy self-administration in two simple steps: removing the cap and pressing the pen against the skin. Moreover, the built-in needle cover ensures that the needle remains concealed prior to administration and automatically locks after use to prevent accidental skin puncture.Rheumatoid arthritis affects an estimated 700,000 - 800,000 individuals in Japan, with methotrexate being a primary treatment option.

笔式自动注射器可以通过两个简单的步骤轻松自我管理:取下盖子并将笔按在皮肤上。此外,内置针头盖确保针头在给药前保持隐藏状态,并在使用后自动锁定,以防止意外皮肤穿刺。类风湿性关节炎在日本估计影响70万至80万人,甲氨蝶呤是主要的治疗选择。

Eisai and nippon medac are dedicated to providing this innovative treatment option to alleviate the challenges faced by rheumatoid arthritis patients. They aim to further contribute to meeting the diverse needs of these patients and enhancing the benefits they receive.Methotrexate (MTX) serves as a cornerstone drug in the treatment of rheumatoid arthritis.

卫材和nippon medac致力于提供这种创新的治疗选择,以缓解类风湿性关节炎患者面临的挑战。他们的目标是进一步促进满足这些患者的不同需求,并提高他们获得的益处。甲氨蝶呤(MTX)是治疗类风湿性关节炎的基石药物。

It is believed to regulate cell growth by inhibiting folate metabolism in lymphocytes and other cells, and al.

据信它通过抑制淋巴细胞和其他细胞中的叶酸代谢来调节细胞生长。