MR编号 | SE/H/1070/004 |
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药品名称 | Octanate LV |
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活性成分 | - blood coagulation factor VIII human 200.0 IU/ml
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剂型 | Powder and solvent for solution for injection |
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上市许可持有人 | Octapharma AB
Sweden |
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参考成员国 - 产品名称 | Sweden (SE) |
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互认成员国 - 产品名称 | - Denmark (DK)
- Belgium (BE)
Octanate 200 IU/ml poeder en oplosmiddel voor injectie - Netherlands (NL)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Octanate LV 200 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Finland (FI)
- Poland (PL)
Octanate LV - Latvia (LV)
Octanate 1000 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai - Lithuania (LT)
Octanate 200 TV/ml milteliai ir tirpiklis injekciniam tirpalui - Cyprus (CY)
OCTANATE C PWD AND SOLVENT FOR SOL FOR INJ - Czechia (CZ)
Octanate (200 IU/ml) - Romania (RO)
Octanate LV 200 UI/ml pulbere şi solvent pentru soluţie injectabilă - Slovenia (SI)
- Malta (MT)
Octanate C 200IU/ml powder and solvent for solution for injection
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许可日期 | 2014/10/13 |
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最近更新日期 | 2025/01/24 |
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药物ATC编码 | - B02BD02 coagulation factor VIII
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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
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附件文件下载 | |
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市场状态 | Positive |
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