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
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common_impack_bottle
Date of last change:2024/09/06
Final Labelling
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common_impack_sachet
Date of last change:2024/09/06
Final Labelling
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common_interpack_clean_inner_cart_multipck
Date of last change:2024/09/06
Final Labelling
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common_outer_bottle
Date of last change:2024/09/06
Final Labelling
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common_outer_sachet
Date of last change:2024/09/06
Final PL
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common_pl
Date of last change:2024/09/06
Final Labelling
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common_pl_clean
Date of last change:2024/09/06
Final PL
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common_spc
Date of last change:2024/09/06
Final Labelling
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common_spc_clean
Date of last change:2024/09/06
Final SPC
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Temozolomide_NL_H_1665_001_006_SmPC_11_07_19
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase