新華製藥(00719.HK)皮膚黏膜過敏仿製藥通過國家藥監局一致性評價
山東新華製藥股份(00719.HK)公布,公司近日收到國家藥品監督管理局核准簽發的鹽酸苯海拉明片(25mg)《藥品補充申請批准通知書》,該產品通過仿製藥質量和療效一致性評價。公司成為國內鹽酸苯海拉明片(25mg)第二家通過仿製藥一致性評價的企業。
鹽酸苯海拉明片為抗過敏類非處方藥品,是醫保工傷用藥,用於皮膚黏膜的過敏,如蕁麻疹、過敏性鼻炎、皮膚瘙癢症、藥疹,對蟲咬症和接觸性鼻炎也有效;該產品亦可用於預防和治療暈動病,有較強的鎮吐作用。
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