欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0453/002
药品名称
Repirol SR
活性成分
ropinirole hydrochloride 4.56 mg
剂型
Prolonged-release tablet
上市许可持有人
PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Praha 7 17000
参考成员国 - 产品名称
Poland (PL)
互认成员国 - 产品名称
许可日期
2011/11/03
最近更新日期
2023/06/30
药物ATC编码
N04BC04 ropinirole
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
2023_06_21_ Repirol SR_PIL_common_PSUSA_06_2023_track
Date of last change:2024/09/06
Final SPC
|
2023_06_26_ Repirol SR_SmPC_common_PSUSA_06_2023_track_upd_22_06_2023
Date of last change:2024/09/06
Final Labelling
|
DE_2132_01_04_R01_Ropinerol_lbl_en_20140808_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_2917_01_04_R01_Ropinerol_outer_en_20140808_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_2918_01_04_R01_Ropinerol_lbl_en_20140808_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_2976_01_04_R01_Ropinerol_lbl_en_20140808_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_2977_01_04_R01_Ropinerol_lbl_en_20140808_renewal
Date of last change:2024/09/06
PubAR
|
PAREN_DE2132_2917_2918_2975_Ropinirol
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase