| MR编号 | NL/H/4994/001 |
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| 药品名称 | Bijuva 1mg/100mg zachte capsules |
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| 活性成分 | - Estradiol hemihydrate 1.0 mg
- Progesterone 100.0 mg
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| 剂型 | Capsule, soft |
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| 上市许可持有人 | Theramex Ireland Limited
3rd Floor, Kilmore House
Spencer Dock, Park Lane
Dublin 1, D01 YE64
Ireland |
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| 参考成员国 - 产品名称 | Netherlands (NL) Bijuva 1mg/100mg zachte capsules |
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| 互认成员国 - 产品名称 | - Malta (MT)
Bijuva Capsules, Soft 1mg/100mg - Germany (DE)
Bijuva 1mg/ 100 mg Weichkapseln - Belgium (BE)
Bijuva 1 mg/100 mg zachte capsules - Portugal (PT)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- France (FR)
- Spain (ES)
- Italy (IT)
- Poland (PL)
Bijuva
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| 许可日期 | 2021/02/25 |
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| 最近更新日期 | 2025/08/19 |
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| 药物ATC编码 | - G03FA04 progesterone and estrogen
| 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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