欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1110/004
药品名称
Pramipexol STADA 0,7 mg Tabletten
活性成分
pramipexole dihydrochloride 1.0 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)
Ireland (IE)
France (FR)
Spain (ES)
Italy (IT)
Sweden (SE)
Finland (FI)
Hungary (HU)
PRAMIPEXOL STADA 0,7 mg tabletta
Romania (RO)
Pramipexol STADA 0,7 mg comprimate
Slovakia (SK)
许可日期
2008/12/04
最近更新日期
2024/03/04
药物ATC编码
N04BC05 pramipexole
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 SPC
|
final_common_spc_DE_H_1110_001_004_IA_038
Date of last change:2024/03/04
Final PL
|
final_common_pl_DE_H_1110_001_004_IA_038
Date of last change:2024/03/04
Final Product Information
|
final-common-PL-1110-033
Date of last change:2020/06/10
Final Product Information
|
final-common-SPC-1110-033
Date of last change:2020/06/10
Final Labelling
|
DE1110_Pramipexol_Lab-inner-0.7mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab-inner-0.35mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab-inner-0.088mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab-inner-1.1mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab--outer-0.7mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab-outer-0.18mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab-outer-0.35mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol_Lab-outer-1.1mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol-Lab-inner-0.18mg_20131031_renewal
Date of last change:2013/10/31
Final Labelling
|
DE1110_Pramipexol-Lab-outer-0.088mg_20131031_renewal
Date of last change:2013/10/31
市场状态
Positive
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