欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1110/001
药品名称
Pramipexol STADA 0,088 mg Tabletten
活性成分
pramipexole dihydrochloride 0.12 mg
剂型
Tablet
上市许可持有人
Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Denmark (DK)
Emwepel
Ireland (IE)
Finland (FI)
Hungary (HU)
PRAMIPEXOL STADA 0,088 mg tabletta
Romania (RO)
Pramipexol STADA 0,088mg comprimate
许可日期
2008/12/04
最近更新日期
2024/05/29
药物ATC编码
N04BC05 pramipexole
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
|
DE1110_Pramipexol_Lab__outer_0_7mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
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DE1110_Pramipexol_Lab_inner_0_088mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
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DE1110_Pramipexol_Lab_inner_0_18mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
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DE1110_Pramipexol_Lab_inner_0_35mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
|
DE1110_Pramipexol_Lab_inner_0_7mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
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DE1110_Pramipexol_Lab_inner_1_1mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
|
DE1110_Pramipexol_Lab_outer_0_088mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
|
DE1110_Pramipexol_Lab_outer_0_18mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
|
DE1110_Pramipexol_Lab_outer_0_35mg_20131031_renewal
Date of last change:2024/09/06
Final Labelling
|
DE1110_Pramipexol_Lab_outer_1_1mg_20131031_renewal
Date of last change:2024/09/06
Final Product Information
|
final_common_PL_1110_033
Date of last change:2024/09/06
Final PL
|
final_common_pl_DE_H_1110_001_004_IA_038
Date of last change:2024/09/06
Final Product Information
|
final_common_SPC_1110_033
Date of last change:2024/09/06
Final SPC
|
final_common_spc_DE_H_1110_001_004_IA_038
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase