欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0544/002
药品名称
Aminoplasmal B. Braun 5 %E
活性成分
Alanine 5.25 g
Arginine 5.75 g
Aspartic acid 2.8 g
Glutamic acid 3.6 g
Glycine 6.0 g
Histidine 1.5 g
Isoleucine 2.5 g
Leucine 4.45 g
Lysine hydrochloride 4.28 g
magnesium chloride hexahydrate 0.51 g
Methionine 2.2 g
Phenylalanine 2.35 g
Potassium acetate 2.45 g
Proline 2.75 g
Serine 1.15 g
Sodium acetate 1.36 g
Sodium hydroxide 0.14 g
Sodium chloride 0.96 g
Threonine 2.1 g
Tryptophan 0.8 g
Tyrosine 0.4 g
Valine 3.1 g
剂型
Solution for infusion
上市许可持有人
B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Czechia (CZ)
Aminoplasmal B. Braun 5% E
Slovakia (SK)
Aminoplasmal B.B.Braun 5% E
Bulgaria (BG)
Aminoplasmal B. Braun
许可日期
2005/06/21
最近更新日期
2025/01/24
药物ATC编码
B05BA10 combinations
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Bibliographic [Article 10.1(a)(ii)]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
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0437_Label_1000_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_clean
Date of last change:2024/09/06
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0437_Label_250_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_clean
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0437_Label_500_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_clean
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0437_Label_500_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_mark_up
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0437_PL_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_final clean
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0437_PL_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_final_mark_up
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0437_SmPC_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_clean
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0437_SmPC_Aminoplasmal_BBraun_50mg_ml_MRP_en_KM_mark_up
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0438_Label_1000_Aminoplasmal_BBraun_50mg_ml_E_MRP_en_KM_clean
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0438_Label_250_Aminoplasmal_BBraun_50mg_ml_E_MRP_en_KM _ Clean
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0438_PL_Aminoplasmal_BBraun_50mg_ml_E_MRP_en_KM_final master text_clean
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0451_Label_500_Aminoplasmal_BBraun_100mg_ml_MRP_en_KM_clean
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0451_Label_500_Aminoplasmal_BBraun_100mg_ml_MRP_en_KM_mark_up
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0451_PL_Aminoplasmal_BBraun_100mg_ml_MRP_en_km_final master texts_clean
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0451_PL_Aminoplasmal_BBraun_100mg_ml_MRP_en_km_final master texts_mark_up
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0451_SmPC_Aminoplasmal_BBraun_100mg_ml_MRP_en_Km_clean
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0451_SmPC_Aminoplasmal_BBraun_100mg_ml_MRP_en_Km_mark_up
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0452_Label_1000_MRP_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_km_clean
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0452_Label_1000_MRP_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_km_mark_up
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0452_Label_500_MRP_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_km_clean
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0452_Label_500_MRP_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_km_mark_up
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0452_PL_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_KM_new_final master texts_clean
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0452_PL_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_KM_new_final master texts_mark_up
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0452_SmPC_Aminoplasmal_BBraun_100mg_ml_E_MRP_en_KM_mark_up
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Final Labelling
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DE_H_543_544_II_03_final labelling_aminoplasmal5e_clean
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Final PL
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DE_H_543_544_II_03_final pl_aminoplasmal5e_clean
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Final SPC
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HR_lab_0438_500_clean_common
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HR_lab_0438_500_markup_common_eng
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HR_lab_0452_500_clean_common_eng
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HR_lab_0452_500_markup_common_eng
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HR_pl_0438_clean_common_eng
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HR_pl_0438_markup_common_eng
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HR_pl_0452_clean_common_eng
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HR_pl_0452_markup_common_eng
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HR_Smpc_0438_clean_common_eng
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HR_Smpc_0438_markup_common_eng
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HR_Smpc_0452_clean_common_eng
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HR_Smpc_0452_markup_common_eng
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Final SPC
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lab_0437_1000_clean_common_eng
Date of last change:2024/09/06
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lab_0437_1000_markup_common_eng
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lab_0437_250_clean_common_eng
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lab_0437_250_markup_common_eng
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lab_0437_500_clean_common_eng
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lab_0437_500_markup_common_eng
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Final SPC
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lab_0438_1000_clean_common
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Final SPC
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lab_0438_1000_markup_common_eng
Date of last change:2024/09/06
Final SPC
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lab_0438_250_clean_common
Date of last change:2024/09/06
Final SPC
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lab_0438_250_markup_common_eng
Date of last change:2024/09/06
Final SPC
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lab_0448_1000_clean_common_eng
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lab_0448_1000_markup_common_eng
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lab_0448_250_clean_common_eng
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lab_0448_250_markup_common_eng
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lab_0448_500_clean_common_eng
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lab_0448_500_markup_common_eng
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lab_0451_1000_clean_common_eng
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lab_0451_1000_markup_common_eng
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lab_0451_250_clean_common_eng
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lab_0451_250_markup_common_eng
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lab_0451_500_clean_common_eng
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lab_0451_500_markup_common_eng
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lab_0452_1000_clean_common
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lab_0452_1000_markup_common_eng
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lab_0452_250_clean_common
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lab_0452_250_markup_common_eng
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PIL_0437_v01_clean_common_eng
Date of last change:2024/09/06
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PIL_0437_v01_markup_common_eng
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pl_0438_clean_common_eng
Date of last change:2024/09/06
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pl_0438_markup_common_eng
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pl_0448_clean_common_eng
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pl_0448_markup_common_eng
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pl_0451_clean_common_eng
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pl_0451_markup_common_eng
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pl_0452_clean_common_eng
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pl_0452_markup_common_eng
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Smpc_0437_clean_common_eng
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Smpc_0437_markup_common_eng
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Smpc_0438_clean_common_eng
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Smpc_0438_markup_common_eng
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smpc_0448_clean_common_eng
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smpc_0448_markup_common_eng
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Final SPC
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Smpc_0451_clean_common_eng
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Smpc_0451_markup_common_eng
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Smpc_0452_clean_common_eng
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Smpc_0452_markup_common_eng
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市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase