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

MR编号	NL/H/0043/004
药品名称	Recombinate
活性成分	octocog alfa 250.0 IU/5ml
剂型	Powder and solvent for solution for injection
上市许可持有人	Baxalta Innovations GmbH Industriestrasse 67 Vienna, A-1221 Austria
参考成员国 - 产品名称	Netherlands (NL) Recombinate 250 IE/5 ml, poeder en oplosmiddel voor oplossing voor injectie
互认成员国 - 产品名称	Belgium (BE) Italy (IT) Lithuania (LT) Recombinate 250 TV/5 ml milteliai ir tirpiklis injekciniam tirpalui
许可日期	2013/02/12
最近更新日期	2023/11/27
药物ATC编码	B02BD02 coagulation factor VIII
申请类型	TypeLevel1：Line Extension TypeLevel2：Additional Strength/Form TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC TypeLevel4：Biological: Blood Product TypeLevel5：Prescription Only
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 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 PIL 10 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-recombinate5ml-sequ41-trackedDate 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-recombinate10ml-sequ41-trackedDate of last change:2020/01/13 PAR \| PAR_0043_004-006_MR_Recombinate_21 mei 2013Date of last change:2013/09/16 Final SPC \| 1.3.1.1 Recombinate SPC version 1.2 cleanDate of last change:2013/05/09
市场状态	Positive