欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
EE/H/0239/001
药品名称
Neiratax
活性成分
cyanocobalamin 1.0 mg
lidocaine hydrochloride 20.0 mg
pyridoxine hydrochloride 100.0 mg
thiamine hydrochloride 100.0 mg
剂型
Solution for injection
上市许可持有人
AS Kalceks Krustpils iela 71E Riga, LV-1057 Latvia
参考成员国 - 产品名称
Estonia (EE)
NEIRATAX
互认成员国 - 产品名称
Netherlands (NL)
Neiraxin B
Poland (PL)
Neiraxin B
Latvia (LV)
Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml šķīdums injekcijām
Lithuania (LT)
Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml injekcinis tirpalas
Hungary (HU)
NEIRATAX 100 mg/100 mg/1 mg/20 mg/2 ml oldatos injekció
Bulgaria (BG)
Neiraxin
Czechia (CZ)
Neiraxin 100 mg/100 mg/1 mg/20 mg/2 ml injekční roztok
Romania (RO)
Neiraxin soluție injectabilă
Slovakia (SK)
Neiraxin B 100 mg/100 mg/1 mg/20 mg/2 ml
Iceland (IS)
许可日期
2017/07/10
最近更新日期
2023/06/05
药物ATC编码
A11DB Vitamin B1 in combination with vitamin B6 and/or vitamin B12
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
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 PL
|
Neiraxin_common_PIL_batch_release_20190701_clean
Date of last change:2019/10/01
Final SPC
|
NeiraxinSPC201712
Date of last change:2018/05/10
PAR Summary
|
EE_H_0239_PAR
Date of last change:2018/05/03
PAR
|
EE_H_0239_PAR
Date of last change:2017/11/08
Final Labelling
|
Neiraxin_common_labelling_outer_clean
Date of last change:2017/09/18
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase