| MR编号 | DE/H/4722/003 |
|---|
| 药品名称 | Oxycodon/Naloxon Krka 40 mg/20 mg Retardtabletten |
|---|
| 活性成分 | - Naloxone hydrochloride 21.8 mg
- Oxycodone hydrochloride 40.0 mg
|
|---|
| 剂型 | Prolonged-release tablet |
|---|
| 上市许可持有人 | KRKA d.d. NOVO mesto
Smarjeska cesta 6
SLO-8501 Novo Mesto
Slovenia |
|---|
| 参考成员国 - 产品名称 | Germany (DE) Oxycodon/Naloxon Krka 40 mg/20 mg Retardtabletten |
|---|
| 互认成员国 - 产品名称 | - Hungary (HU)
OXYNADOR 40 mg/20 mg retard tabletta - Bulgaria (BG)
Adolax 40 mg/ 20 mg prolonged-release tablets - Czechia (CZ)
Adolax 40 mg/20 mg, Tableta s prodlouženým uvolňováním - Romania (RO)
- Slovakia (SK)
Adolax 40 mg/20 mg - Slovenia (SI)
Adolax 40 mg/20 mg tablete s podaljšanim sproščanjem - Croatia (HR)
Adolax 40 mg/20 mg tablete s produljenim oslobađanjem - Spain (ES)
- Denmark (DK)
Oxycodon/Naloxon Krka - Belgium (BE)
Oxycodon/Naloxon Krka 40 mg/20 mg tabletten met verlengde afgifte - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Sweden (SE)
- Finland (FI)
- Poland (PL)
Oxynador - Latvia (LV)
Oxynador 40 mg + 20 mg ilgstošās darbības tabletes - Lithuania (LT)
Dolnada 40 mg / 20 mg pailginto atpalaidavimo tabletės - Estonia (EE)
NOLDOXEN
|
|---|
| 许可日期 | 2017/03/24 |
|---|
| 最近更新日期 | 2024/10/28 |
|---|
| 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 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|