欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/1207/002
药品名称
Proximic
活性成分
amlodipine besilate 10.0 mg
indapamide 1.25 mg
PERINDOPRIL ARGININE 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Day Zero ehf. Reykjavíkurvegi 62 Hafnarfjördur 220 Iceland
参考成员国 - 产品名称
Czechia (CZ)
Proximic
互认成员国 - 产品名称
Poland (PL)
Kurstrelli
Slovakia (SK)
许可日期
2024/07/17
最近更新日期
2024/07/18
药物ATC编码
C09BX01 perindopril, amlodipine and indapamide
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
PubAR
|
PROXIMIC_PAR_44634_22_ 44635_22_ 44637_22_ 44638_22
Date of last change:2024/11/06
Final Labelling
|
CTS perindopril_arginine_indapamide_amlodipine_cz_h_1207_001_004_dc_oup_clean
Date of last change:2024/09/06
Final SPC
|
perindopril_arginine_indapamide_amlodipine_cz_h_1195_1207_001_004_dc_smpc_19_04_2024_clean
Date of last change:2024/09/06
Final PL
|
perindopril_arginine_indapamide_amlodipine_cz_h_1207_001_004_dc_pil_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase