| MR编号 | DE/H/4722/001 |
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| 药品名称 | Oxycodon/Naloxon Krka 10 mg/5 mg Retardtabletten |
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| 活性成分 | - Naloxone hydrochloride 5.45 mg
- Oxycodone hydrochloride 10.0 mg
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| 剂型 | Prolonged-release tablet |
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| 上市许可持有人 | KRKA d.d. NOVO mesto
Smarjeska cesta 6
SLO-8501 Novo Mesto
Slovenia |
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| 参考成员国 - 产品名称 | Germany (DE) Oxycodon/Naloxon Krka 10 mg/5 mg Retardtabletten |
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| 互认成员国 - 产品名称 | - Denmark (DK)
Oxycodon/Naloxon Krka - Belgium (BE)
Oxycodon/Naloxon Krka 10 mg/5 mg tabletten met verlengde afgifte - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Portugal (PT)
- Sweden (SE)
- Finland (FI)
- Poland (PL)
Oxynador - Latvia (LV)
Oxynador 10 mg + 5 mg ilgstošās darbības tabletes - Lithuania (LT)
Dolnada 10 mg / 5 mg pailginto atpalaidavimo tabletės - Estonia (EE)
NOLDOXEN - Hungary (HU)
OXYNADOR 10 mg/5 mg retard tabletta - Bulgaria (BG)
Adolax 10 mg/ 5 mg prolonged-release tablets - Czechia (CZ)
Adolax 10 mg/5 mg, Tableta s prodlouženým uvolňováním - Romania (RO)
- Slovakia (SK)
Adolax 10 mg/5 mg - Slovenia (SI)
Adolax 10 mg/5 mg tablete s podaljšanim sproščanjem - Croatia (HR)
Adolax 10 mg/5 mg tablete s produljenim oslobađanjem
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| 许可日期 | 2017/03/24 |
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| 最近更新日期 | 2024/12/12 |
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| 药物ATC编码 | - N02AA55 oxycodone and naloxone
| 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
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| 附件文件下载 | |
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| 市场状态 | Positive |
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