欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5064/002
药品名称
Sunitinib Dr Reddy’s
活性成分
SUNITINIB 25.0 mg
剂型
Capsule, hard
上市许可持有人
Betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Spain (ES)
Italy (IT)
Romania (RO)
Malta (MT)
Germany (DE)
Sunitinib beta 25 mg Hartkapseln
许可日期
2021/04/23
最近更新日期
2024/06/10
药物ATC编码
L01XE04 sunitinib
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 PL
|
common_pl_clean_0012
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_0012
Date of last change:2024/09/06
PubAR Summary
|
NL_H_5064_001_004 Sunitinib Betapharm sPAR EN
Date of last change:2024/09/06
PubAR
|
PAR_5064_Sunitinib Betapharm 001_002_004_2_9_2021
Date of last change:2024/09/06
市场状态
Positive
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