欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2289/002
药品名称
Zopiclone Grindeks
活性成分
Zopiclone 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Grindeks AS
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Slovakia (SK)
Greece (GR)
Slovenia (SI)
Germany (DE)
Zopiclone Baltijos Bite 5 mg Filmtabletten
Norway (NO)
Croatia (HR)
Denmark (DK)
Somnols
Finland (FI)
Belgium (BE)
Zopiclone Grindeks 5 mg filmomhulde tabletten
Poland (PL)
Zopiclone Baltijos Bitė
Netherlands (NL)
Latvia (LV)
Luxembourg (LU)
Lithuania (LT)
Zopiclone Baltijos Bitė 5 mg plėvele dengtos tabletės
Ireland (IE)
Estonia (EE)
Austria (AT)
Hungary (HU)
Zopiclone Baltijos Bite
France (FR)
Bulgaria (BG)
Zopiclone Baltijos Bite
Spain (ES)
Czechia (CZ)
ZOPICLONE BALTIJOS BITE
Portugal (PT)
Romania (RO)
Zopiclone Baltijos Bite 5 mg comprimate filmate
Italy (IT)
许可日期
2024/08/21
最近更新日期
2024/10/10
药物ATC编码
N05CF01 zopiclone
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
Final PL
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Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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