欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	DE/H/4259/002
药品名称	Oxycodon comp.-AbZ 10 mg/5 mg Retardtabletten
活性成分	NALOXONE HYDROCHLORIDE hydrochloride 5.45 mg oxycodone hydrochloride 10.0 mg
剂型	Prolonged-release tablet
上市许可持有人	AbZ-Pharma GmbH - Geschäftsanschrift - Graf-Arco-Str. 3 89079 Ulm Germany
参考成员国 - 产品名称	Germany (DE) Oxycodon HCl AbZ comp 10/5 mg Retardtabletten
互认成员国 - 产品名称	Spain (ES) Italy (IT) Sweden (SE) Finland (FI) Poland (PL) Oxycodone + Naloxone Teva Bulgaria (BG) Oxycodone/Naloxone Teva Croatia (HR) Oksikodon/nalokson Pliva 10 mg/5 mg tablete s produljenim oslobađanjem
许可日期	2015/12/02
最近更新日期	2024/03/25
药物ATC编码	N02AA55 oxycodone and naloxone
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 \| IS_H_0304_001_003_005_IA_015_PIL_Clean_Oxycodone_Naloxone_Alvogen_29_4_2022Date of last change:2022/06/02 Final SPC \| IS_H_0304_001_003_005_IA_015_SmPC_Clean_Oxycodone_Naloxone_Alvogen_29_4_2022Date of last change:2022/06/02 Final SPC \| IS_H_0357_001_IA_010_SmPC_Clean_Oxycodone_alvogen_27_4_2022Date of last change:2022/06/02 Final Product Information \| final-common-outer-4259-021Date of last change:2021/12/02 Final Product Information \| final-common-PL-4259-021Date of last change:2021/12/02 Final Product Information \| final-common-SPC-4259-021Date of last change:2021/12/02 PAR \| PAREN-DE 4259 4264_Oxycodon Naloxon AbZDate of last change:2017/07/25
市场状态	Positive