欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/3234/003
药品名称
SIRANALEN 300 mg
活性成分
Pregabalin 75.0 mg
剂型
Capsule, hard
上市许可持有人
Medochemie Ltd. 1-10 Constantinoupoleos Street 3011 Limassol
参考成员国 - 产品名称
Netherlands (NL)
SIRAN
互认成员国 - 产品名称
Estonia (EE)
SIRANALEN
Slovenia (SI)
Lithuania (LT)
SIRANALEN 75 mg kietosios kapsulės
Greece (GR)
SIRAN
Cyprus (CY)
Romania (RO)
SIRANALEN 300 mg capsule
Slovakia (SK)
Siranalen 75 mg tvrdé kapsuly
Malta (MT)
Siran 75mg hard capsules
Croatia (HR)
许可日期
2016/05/25
最近更新日期
2024/12/31
药物ATC编码
N03AX16 pregabalin
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
|
180108 NL_H_3234_001_003_DC Siranalen PAR
Date of last change:2024/09/06
PubAR Summary
|
180108 NL_H_3234_001_003_DC Siranalen summary EN
Date of last change:2024/09/06
Final PL
|
Common PIL
Date of last change:2024/09/06
Final SPC
|
Common SmpC
Date of last change:2024/09/06
Final Labelling
|
common_combined_labelling_Nov2020_clean_EoP15052021
Date of last change:2024/09/06
市场状态
Positive
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