欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/0339/001
药品名称
Elidel
活性成分
pimecrolimus 1.0 mg/g
剂型
Cream
上市许可持有人
Viatris ApS Borupvang 1 2750 Ballerup Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Slovenia (SI)
Malta (MT)
Germany (DE)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Elidel 1 % Krem
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Elidel 1% Creme
Spain (ES)
Portugal (PT)
Elidel
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
Bulgaria (BG)
Elidel
Romania (RO)
Elidel
Latvia (LV)
Elidel 10 mg/g krēms
Lithuania (LT)
Elidel 10 mg/g kremas
Estonia (EE)
ELIDEL
Hungary (HU)
ELIDEL 10 mg/g krém
Cyprus (CY)
Czechia (CZ)
Slovakia (SK)
许可日期
2002/08/06
最近更新日期
2024/04/02
药物ATC编码
D11AX Other dermatologicals
申请类型
TypeLevel1：
New Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Article 4.8 Di 65/65
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
common_pl_var_ii
Date of last change:2022/06/02
Final SPC
|
Final common-SmPC- DK_H_0339_001_II_075
Date of last change:2021/10/29
Final PL
|
Final common-PL- DK_H_0339_001_II_075
Date of last change:2021/10/29
Final Labelling
|
IP_Elidel_1808
Date of last change:2018/11/28
Final Labelling
|
OP_Elidel_1810_
Date of last change:2018/11/28
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase