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

MR编号	NL/H/0043/002
药品名称	Recombinate 500 IU
活性成分	octocog alfa 500.0 U
剂型	Powder and solvent for solution for injection
上市许可持有人	Baxter, Energielaan 3, 5405 AD UDEN, The Netherlands
参考成员国 - 产品名称	Netherlands (NL)
互认成员国 - 产品名称	Belgium (BE) Italy (IT) Greece (GR)
许可日期	1993/05/12
最近更新日期	2023/11/27
药物ATC编码	B02BD02 coagulation factor VIII
申请类型	TypeLevel1：[not specified] TypeLevel2：[not specified] TypeLevel3：Full Dossier Article 4.8 Di 65/65 TypeLevel4：[not specified] TypeLevel5：[not specified]
附件文件下载	Final Product Information \| Common Label 5 ml cleanDate of last change:2021/07/20 Final Product Information \| Common Label 10 ml cleanDate of last change:2021/07/20 Final Product Information \| Common PIL 10 ml cleanDate of last change:2021/07/20 Final Product Information \| Common PIL 5 ml cleanDate of last change:2021/07/20 Final Product Information \| Common SmPC 5 ml cleanDate of last change:2021/07/20 Final Product Information \| Common SmpC 10 ml cleanDate of last change:2021/07/20 Final PL \| common-combined-pi-recombinate5ml-sequ41-cleanDate of last change:2020/01/13 Final PL \| common-combined-pi-recombinate10ml-sequ41-cleanDate of last change:2020/01/13 Final PL \| common-combined-pi-recombinate5ml-sequ41-trackedDate of last change:2020/01/13 Final PL \| common-combined-pi-recombinate10ml-sequ41-trackedDate of last change:2020/01/13 Final SPC \| common_spc_clean_variation53_spcDate of last change:2013/05/21
市场状态	Positive