欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1431/001
药品名称
Injexate
活性成分
Methotrexate 50.0 mg/ml
剂型
Solution for injection in prefilled syringe
上市许可持有人
Accord Healthcare B.V. The Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Greece (GR)
Germany (DE)
Methofill 50 mg/ml Injektionslösung in einer Fertigspritze
Denmark (DK)
Injexate
Belgium (BE)
Methofill 50 mg/ml oplossing voor injectie in een voorgevulde spuit
Netherlands (NL)
Injexate oplossing voor injectie in voorgevulde spuit
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Methofill 50 mg/ml Injektionslösung in einer Fertigspritze
France (FR)
Italy (IT)
Norway (NO)
Finland (FI)
Poland (PL)
Methofill
Lithuania (LT)
Metother 50 mg/ml injekcinis tirpalas užpildytame švirkšte
Hungary (HU)
METHOFILL 50 mg/ml oldatos injekció előretöltött fecskendőben
Bulgaria (BG)
Injexate
Cyprus (CY)
Czechia (CZ)
Injexate 50 mg/ ml injekční roztok
Slovenia (SI)
Croatia (HR)
Slovakia (SK)
许可日期
2015/10/01
最近更新日期
2025/06/26
药物ATC编码
L04AX03 methotrexate
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
|
Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase