欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	DE/H/2021/006
药品名称	Tapentadol Libra-Pharm retard 150 mg Retardtabletten
活性成分	tapentadol hydrochloride 174.72 mg
剂型	Prolonged-release tablet
上市许可持有人	Libra-Pharm GmbH Zieglerstr. 6 52078 Aachen Germany
参考成员国 - 产品名称	Germany (DE) Yantil retard; 150 mg
互认成员国 - 产品名称	United Kingdom (Northern Ireland) (XI) Portugal (PT) Austria (AT) Spain (ES) Italy (IT)
许可日期	2010/08/10
最近更新日期	2024/07/04
药物ATC编码	N02AX06 tapentadol
申请类型	TypeLevel1：New Active Substance TypeLevel2：Additional Strength/Form TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final PL \| common_final_pl_2021_004_008__V049Date of last change:2023/03/16 Final SPC \| common_final_spc_2021_004_009__V049Date of last change:2023/01/20 Final Product Information \| final-common-pL-2021-028-RET-25Date of last change:2019/01/15 Final Product Information \| final-common-pL-2021-028-RET-50-250Date of last change:2019/01/15 Final Product Information \| final-common-PL-2021-028-4-20Date of last change:2019/01/15 Final Product Information \| final-common-pL-2021-028-50-100Date of last change:2019/01/15 Final Product Information \| final-common-SMPC-2021-028-25-250Date of last change:2019/01/15 Final Product Information \| final-common-SMPC-2021-028-4-20Date of last change:2019/01/15 Final Product Information \| final-common-SMPC-2021-028-50-100Date of last change:2019/01/15
市场状态	Positive