| MR编号 | DK/H/1059/010 |
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| 药品名称 | Quetiapin "Krka" |
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| 活性成分 | - quetiapine hemifumarate 400.0 mg
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| 剂型 | Prolonged-release tablet |
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| 上市许可持有人 | Krka Sverige AB
Göta Ark 175, Medborgarplatsen 25
11872 Stockholm
Sweden |
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| 参考成员国 - 产品名称 | Denmark (DK) Quetiapin Krka |
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| 互认成员国 - 产品名称 | - Estonia (EE)
KVENTIAX SR - Bulgaria (BG)
Kventiax SR - Czechia (CZ)
Kventiax Prolong 400 mg - Romania (RO)
Kventiax EP 400 mg comprimate cu eliberare prelungită - Slovakia (SK)
- Slovenia (SI)
Kventiax SR 400 mg tablete s podaljšanim sproščanjem - Iceland (IS)
- Germany (DE)
Quetiapin TAD 400 mg Retardtabletten - Belgium (BE)
Quetiapine Krka - Ireland (IE)
- Austria (AT)
Quetiapin HCS 400 mg Retardtabletten - France (FR)
- Spain (ES)
- Italy (IT)
- Greece (GR)
QUENTIAX® SR - Sweden (SE)
- Finland (FI)
- Poland (PL)
Kventiax SR - Latvia (LV)
Kventiax 400 mg ilgstošās darbības tabletes - Lithuania (LT)
Kventiax 400 mg pailginto atpalaidavimo tabletės
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| 许可日期 | 2018/06/21 |
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| 最近更新日期 | 2025/04/14 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Additional Strength/Form
- 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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