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中關村(000931.SZ):氨酚曲馬多片一致性評價獲國家藥監局受理
格隆匯 03-24 17:59

格隆匯3月24日丨中關村(000931.SZ)公佈,近日,公司全資子公司北京中關村四環醫藥開發有限責任公司之控股子公司多多藥業有限公司(以下簡稱:多多藥業)收到國家藥品監督管理局(以下簡稱:國家藥監局)下發的氨酚曲馬多片一致性評價《受理通知書》。

申請事項:境內生產藥品一致性評價申請:國家藥品監管部門審批的補充申請事項,l.已上市化學藥品藥學變更相關技術指導原則中屬於重大變更的事項;l.2變更製劑處方中的輔料;l.3變更製劑生產工藝;l.5變更生產批量;l.6變更註冊標準;1.8變更有效期和貯藏條件;5.國家藥品監管部門規定需要審批的其他事項。

多多藥業有限公司的氨酚曲馬多片(規格:每片含鹽酸曲馬多37.5mg和對乙酰氨基酚325mg)於2012年獲批上市,藥品批准文號為國藥準字H20120040。本次申報產品適應症為用於中度至重度急性疼痛的短期(5天或更短)治療。

多多藥業的氨酚曲馬多片一致性評價獲得國家藥監局的受理,標誌着該品種一致性評價工作進入審查階段,公司將積極推進後續相關工作,如通過一致性評價,將增加該品種的市場競爭力,對公司的經營業績產生積極的影響。

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