欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1665/004
药品名称
Temozolomide ratiopharm, 140 mg
活性成分
temozolomide 5.0 mg
剂型
Capsule, hard
上市许可持有人
Ratiopharm GmbH Graf Arcostr. 3 89079 Ulm Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Iceland (IS)
Germany (DE)
Finland (FI)
许可日期
2010/02/23
最近更新日期
2024/04/30
药物ATC编码
L01AX03 temozolomide
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
common-spc-clean
Date of last change:2020/11/17
Final Labelling
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common-interpack-clean-inner-cart-multipck
Date of last change:2020/11/17
Final Labelling
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common-pl-clean
Date of last change:2020/11/17
Final Labelling
|
common-impack-bottle
Date of last change:2020/11/17
Final Labelling
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common-impack-sachet
Date of last change:2020/11/17
Final Labelling
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common-outer-bottle
Date of last change:2020/11/17
Final Labelling
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common-outer-sachet
Date of last change:2020/11/17
Final SPC
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Temozolomide-NL-H-1665_001-006-SmPC-11.07.19
Date of last change:2019/09/26
Final PL
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common-pl
Date of last change:2018/07/09
Final PL
|
common-spc
Date of last change:2018/07/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase