欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0237/001
药品名称
Gadovist 0,5 mmol/ml
活性成分
gadobutrol 302.0 mg
剂型
Solution for injection
上市许可持有人
Schering Deutschland GmbH Max-Dohrn-Str. 10 D-10589 Berlin
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Gadovist
United Kingdom (Northern Ireland) (XI)
Gadovist
Ireland (IE)
France (FR)
GADOVIST
Spain (ES)
GADOVIST 0,5 mmol/ml solución inyectable
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Gadovist
Norway (NO)
Finland (FI)
许可日期
2000/06/15
最近更新日期
2024/08/19
药物ATC编码
V VARIOUS
V08 CONTRAST MEDIA
V08C MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08CA Paramagnetic contrast media
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
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市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase