欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0231/001
药品名称
Hydroxyurea medac
活性成分
Hydroxycarbamide 500.0 mg
剂型
Capsule, hard
上市许可持有人
Medac Gesellschaft für klinische Spezialpräparate GmbH Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Slovakia (SK)
Germany (DE)
Denmark (DK)
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Hydroxyurea medac 500 mg Hartkapseln
Portugal (PT)
Hydroxyurea medac
Norway (NO)
Finland (FI)
Iceland (IS)
Spain (ES)
许可日期
2000/12/21
最近更新日期
2024/10/07
药物ATC编码
L01XX05 hydroxycarbamide
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Bibliographic Article 4.8 (a) (ii)
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_0231_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0231_001_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase