欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/1483/003
药品名称
Ropinirol AbZ 1 mg Filmtabletten
活性成分
ropinirole hydrochloride 1.14 mg
剂型
Film-coated tablet
上市许可持有人
AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Netherlands (NL)
Ropinirolhydrochloride 1 mg PCH
France (FR)
Portugal (PT)
许可日期
2008/12/10
最近更新日期
2024/05/22
药物ATC编码
N04BC04 ropinirole
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 Product Information
|
common_final_labip_1483_V025
Date of last change:2024/09/06
Final Product Information
|
common_final_labop_1483_V025
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_1483_V025
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_1483_V025
Date of last change:2024/09/06
Final PL
|
final_common_PL_DE_H_1483_001_004_IA_029
Date of last change:2024/09/06
Final SPC
|
final_common_SmPC_DE_H_1483_001_004_IA_029
Date of last change:2024/09/06
PubAR
|
PAREN_DE1483_DC_Ropinirol_20100317_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase