欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2691/001
药品名称
Dropizol
活性成分
OPIUM 10.0 mg/ml
剂型
Oral drops, solution
上市许可持有人
Pharmanovia A/S Ørestads Boulevard 108 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
Dropizol
互认成员国 - 产品名称
Iceland (IS)
Dropizol 10 mg/ml dropar til inntöku, lausn
United Kingdom (Northern Ireland) (XI)
Sweden (SE)
Norway (NO)
Dropizol
Finland (FI)
Germany (DE)
Dropizol 10 mg/ml Tropfen zum Einnehmen, Lösung
Belgium (BE)
Ireland (IE)
Luxembourg (LU)
Netherlands (NL)
Austria (AT)
Czechia (CZ)
Dropizol
Spain (ES)
France (FR)
Hungary (HU)
DROPIZOL 10 mg/ml belsőleges oldatos cseppek
Italy (IT)
Portugal (PT)
Romania (RO)
Slovakia (SK)
许可日期
2017/08/15
最近更新日期
2024/10/02
药物ATC编码
A07DA02 opium
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pil_clean_DKMA
Date of last change:2024/10/02
Final SPC
|
common_spc_clean_DKMA
Date of last change:2024/10/02
Final Labelling
|
common_interpack_clean
Date of last change:2024/09/06
Final Product Information
|
dropizol_pil_track
Date of last change:2024/09/06
PubAR
|
Module 6 PAR update DK_H_2691_001_DC Dropizol
Date of last change:2024/09/06
PubAR
|
PAR DK_H_2691_001_DC _ Dropizol
Date of last change:2024/09/06
PubAR Summary
|
sPAR DK_H_2691_001_DC _ Dropizol
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase