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

MR编号	AT/H/0154/002
药品名称	Immunate 500 I.E.
活性成分	blood coagulation factor VIII human 250.0 IU
剂型	Powder and solvent for solution for injection
上市许可持有人	Baxter AG A-1220 Wien
参考成员国 - 产品名称	Austria (AT) Immunate 500 I.E. - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
互认成员国 - 产品名称	Finland (FI) Bulgaria (BG) Romania (RO) Immunate 500 UI pulbere si solvent pentru solutie injectabila Slovenia (SI) Portugal (PT) Italy (IT) Poland (PL) Immunate Baxter 500 Latvia (LV) Lithuania (LT) IMMUNATE Baxter 500 TV milteliai ir tirpiklis injekciniam tirpalui Estonia (EE) IMMUNATE BAXTER 500 Hungary (HU) IMMUNATE S/D 500 NE por és oldószer oldatos injekcióhoz Cyprus (CY) Czechia (CZ) Slovakia (SK) Malta (MT)
许可日期	2005/08/31
最近更新日期	2023/07/25
药物ATC编码	B02BD06 von Willebrand factor and coagulation factor VIII in combination
申请类型	TypeLevel1：Known Active Substance TypeLevel2：Additional Strength/Form TypeLevel3：Full Dossier [Article 8.3(i)] TypeLevel4：Biological: Blood Product TypeLevel5：Prescription Only
附件文件下载	Final PL \| Common English PIL_clean_ FEIBA_ 50 Uml_ powder and solvent for solution for infusion_ EU_ _en__ 23_Dec_2021Date of last change:2022/06/02 Final PL \| common_pil_immunine 200 IU_Jan 2022Date of last change:2022/06/02 Final PL \| Common English PIL_clean_ FEIBA_ 25 Uml_ powder and solvent for solution for infusion_ EU_ _en__ 23_DEC_2021Date of last change:2022/06/02 Final PL \| common_pil_immunate250fviii_190iuvwfpowderib63 cleanDate of last change:2022/06/02 Final PL \| common_pil_immunine 600 IU_Jan 2022Date of last change:2022/06/02 Final PL \| common_pil_immunate500fviii_375iuvwfpowderib63 cleanDate of last change:2022/06/02 Final PL \| common_pil_immunate1000fviii_750iuvwfpowderib63 cleanDate of last change:2022/06/02 Final PL \| common_pil_immunine 1200 IU_Jan 2022Date of last change:2022/06/02 Final Product Information \| Common English combined SmPC PIL Label_ Prothromplex Total_ 600 IU_ powder and solvent for solution for injection_ EU_ _en__ Jan 2022 cleanDate of last change:2022/02/14 PAR \| PAR_scientific_discussionDate of last change:2021/11/09 Final SPC \| common-spc-immunate1000fviii-750iuvwfpowderib63cleanDate of last change:2021/05/12 Final SPC \| common-spc-immunante500fviii-375iuvwfpowderib63cleanDate of last change:2021/05/12 Final SPC \| common-spc-immunate250fviii-190iuvwfpowderib63cleanDate of last change:2021/05/12 Final Labelling \| LAB_Immunate_500iu_07Jun2017_cleanDate of last change:2017/07/26
市场状态	Positive