| MR编号 | NL/H/0855/001 |
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| 药品名称 | Azyter, eye drops, solution, 15 mg/g |
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| 活性成分 | - Azithromycin dihydrate 15.0 mg/g
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| 剂型 | Eye drops, solution |
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| 上市许可持有人 | Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France |
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| 参考成员国 - 产品名称 | Netherlands (NL) |
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| 互认成员国 - 产品名称 | - Austria (AT)
Azyter 15 mg/g Augentropfen im Einzeldosisbehältnis - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Poland (PL)
Azyter - Iceland (IS)
- Hungary (HU)
AZYTER 15mg/g egyadagos oldatos szemcsepp - Denmark (DK)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Greece (GR)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Bulgaria (BG)
AZYTER - Cyprus (CY)
AZYTER EYE DROPS - Czechia (CZ)
AZYTER - Romania (RO)
AZYTER 15 mg/g picături oftalmice, soluţie în recipient unidoză - Slovenia (SI)
- Germany (DE)
- Luxembourg (LU)
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| 许可日期 | 2007/07/27 |
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| 最近更新日期 | 2025/05/29 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1:Known Active Substance
- TypeLevel2:Initial Application
- TypeLevel3:Full Dossier Art 8.3(i) 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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