步長製藥(603858.SH)獲得藥品補充申請批件 涉及龍珠平亢丸
格隆匯11月1日丨步長製藥(603858.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的藥品補充申請批件,藥品名稱為龍珠平亢丸,申請內容為藥品生產技術轉讓。
龍珠平亢丸是中藥製劑,由玄蔘、龍膽、地黃、麥冬等十五味藥材組成。本品具有滋陰清火、養心寧神、化痰軟堅的功能,用於陰虛火旺型甲狀腺機能亢進症所致之惡熱、食慾亢進、心悸、心煩、多汗、疲乏、手顫等症狀。本品研發投入為2035.69萬元。
根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,同意吉林省輝南長龍生化藥業股份有限公司將龍珠平亢丸的藥品生產技術轉讓給山東步長製藥股份有限公司,發給藥品生產文號,同時撤銷吉林省輝南長龍生化藥業股份有限公司該品種的藥品批准文號。規格:每袋裝4g(相當於飲片16.88g)。有效期:18個月。註冊標準執行國家食品藥品監督管理總局“龍珠平亢丸”(標準編號:YBZ00292004-2015Z)的有關規定,其中修訂“製法”,“規格”部分內容,生產企業信息替換為山東步長製藥股份有限公司的有關信息。
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