白雲山(00874.HK)分公司獲得藥品補充申請批件
格隆匯5月28日丨白雲山(00874.HK)公告,近日,廣州白雲山醫藥集團股份有限公司(“公司”)分公司廣州白雲山醫藥集團股份有限公司白雲山何濟公製藥廠(“何濟公製藥廠”)收到國家藥品監督管理局(“國家藥監局”)簽發的《藥品補充申請批準通知書》。
藥品通用名稱:口潔噴霧劑。申請內容:變更藥品說明書中安全性等內容。審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批準本品變更藥品說明書中安全性等內容的補充申請。具體修訂如下:【不良反應】監測數據顯示,本品可見以下不良反應:噁心、嘔吐、味覺喪失、腹瀉、瘙癢、皮疹、過敏性皮炎、頭暈、外用藥部位疼痛等。【禁忌】1.對乙醇(酒精)過敏者禁用。2.對本品及所含成份過敏者禁用。【注意事項】第4項修訂爲“4.孕婦慎用。”第8項修訂爲“8.過敏體質者慎用。”第10項修訂爲“10.本品含乙醇(酒精),服藥期間不得駕駛機、車、船,從事高空作業、機械作業及操作精密儀器。”其餘內容不變。
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