欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/3658/001
药品名称
Ceftriaxon Eberth 0,5 g Pulver zur Herstellung einer Injektionslösung
活性成分
ceftriaxone disodium 0.6 mg
剂型
Powder for solution for injection
上市许可持有人
Dr. Friedrich Eberth Arzneimittel GmbH Am Bahnhof 2 D-92289 Ursensollen Germany
参考成员国 - 产品名称
Germany (DE)
Ceftriaxon Pharma Resources 0,5 g Pulver zur Herstellung einer Injektionslösung
互认成员国 - 产品名称
Austria (AT)
许可日期
2013/09/04
最近更新日期
2020/05/29
药物ATC编码
J01DD04 ceftriaxone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
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DE_3658_002_pal-common_Ceftri_E_1g_Plv_v7-4_2020-05-27_clean_20200529_renewal
Date of last change:2020/05/29
Final SPC
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DE_3658_002_spc-common_Ceftri_E_1g_Plv_v8-3_2020-05-27_clean._20200529_renewal
Date of last change:2020/05/29
Final SPC
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DE_3658_003_spc-common_Ceftri_E_2g_Plv_v8-3_2020-05-27_clean_20200529_renewal
Date of last change:2020/05/29
Final SPC
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DE_3658_004_spc-common_Ceftri_E_2g_Plv+LM_v8-3_2020-05-27_clean._20200529_renewal
Date of last change:2020/05/29
Final Labelling
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DE_3658_002_labop-common_Ceftri_E_1g_Plv_v6-1_2020-04-29_clean_20200529_renewal
Date of last change:2020/05/29
Final PL
|
DE_3658_003_pal-common_Ceftri_E_2g_Plv_v8-4_2020-05-27_clean_20200529_renewal
Date of last change:2020/05/29
Final Labelling
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DE_3658_002_labip-common_Ceftri_E_1g_Plv_v7-1_2020-04-15_clean_20200529_renewal
Date of last change:2020/05/29
Final PL
|
DE_3658_004_pal-common_Ceftri_E_2g_Plv+LM_v8-4_2020-05-27_clean_20200529_renewal
Date of last change:2020/05/29
Final Labelling
|
DE_3658_004_labop-common_Ceftri_E_2g_Plv+LM_v6-1_2020-04-29_clean._20200529_renewal
Date of last change:2020/05/29
Final Labelling
|
DE_3658_003_labip-common_Ceftri_E_2g_Plv_v7-1_2020-04-15_clean_20200529_renewal
Date of last change:2020/05/29
Final Labelling
|
DE_3658_003_labop-common_Ceftri_E_2g_Plv_v6-1_2020-04-29_clean_20200529_renewal
Date of last change:2020/05/29
Final Labelling
|
DE_3658_004_labip-common_Plv_Ceftri_E_2g_Plv+LM_v7-1_2020-04-30_clean_20200529_renewal
Date of last change:2020/05/29
PAR
|
PAREN-DE3658_Ceftriaxon-20140204
Date of last change:2014/02/04
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase