欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4801/001
药品名称
Chantico 0,5 mg capsules
活性成分
fingolimod hydrochloride 0.5 mg
剂型
Capsule, hard
上市许可持有人
G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Austria (AT)
Fingolya 0,5 mg-Hartkapseln
Poland (PL)
Chantico
Latvia (LV)
Chantico 0,5 mg cietās kapsulas
Lithuania (LT)
Chantico 0,5 mg kietosios kapsulės
Estonia (EE)
CHANTICO
Hungary (HU)
CHANTICO 0,5 mg kemény kapszula
Bulgaria (BG)
Chantico
Czechia (CZ)
Finsklerosis
Slovakia (SK)
Chantico 0,5 mg tvrdé kapsuly
许可日期
2020/05/07
最近更新日期
2024/10/09
药物ATC编码
L04AA27 fingolimod
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 SPC
|
common spc
Date of last change:2024/09/06
Final Product Information
|
common_pl clean
Date of last change:2024/09/06
PubAR
|
PAR_4801_Chantico_6 aug 2020
Date of last change:2024/09/06
PubAR Summary
|
summaryPAR_4801_Chantico_6 aug 2020_EN
Date of last change:2024/09/06
市场状态
Positive
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