| 商品名称 | 适用类别 | 通用名称 | 活性成分 | 产品号 | 上市许可开发者/申请人/持有人 | 上市许可日期 | 许可状态 |
|---|---|---|---|---|---|---|---|
| Imaavy | Human | nipocalimab | nipocalimab | EMEA/H/C/006379 | Janssen Cilag International NV | 2025/11/28 | Authorised |
| Kyinsu | Human | insulin icodec;semaglutide | insulin icodec;semaglutide | EMEA/H/C/006279 | Novo Nordisk A/S | 2025/11/24 | Authorised |
| Rivaroxaban Koanaa | Human | rivaroxaban | rivaroxaban | EMEA/H/C/006643 | Koanaa Healthcare GmbH | 2025/11/21 | Authorised |
| Brinsupri | Human | Brensocatib | Brensocatib monohydrate | EMEA/H/C/005820 | Insmed Netherlands B.V. | 2025/11/18 | Authorised |
| Kefdensis | Human | denosumab | denosumab | EMEA/H/C/006490 | Stada Arzneimittel AG | 2025/11/17 | Authorised |
| Xbonzy | Human | denosumab | denosumab | EMEA/H/C/006722 | Reddy Holding GmbH | 2025/11/17 | Authorised |
| Acvybra | Human | denosumab | denosumab | EMEA/H/C/006734 | Reddy Holding GmbH | 2025/11/17 | Authorised |
| Ponlimsi | Human | denosumab | denosumab | EMEA/H/C/006238 | Teva GmbH | 2025/11/17 | Authorised |
| Degevma | Human | denosumab | denosumab | EMEA/H/C/006239 | Teva GmbH | 2025/11/17 | Authorised |
| Zvogra | Human | denosumab | denosumab | EMEA/H/C/006552 | Stada Arzneimittel AG | 2025/11/17 | Authorised |
| Denosumab Intas | Human | denosumab | denosumab | EMEA/H/C/006797 | Intas Third Party Sales 2005 S.L. | 2025/11/17 | Authorised |
| Lynkuet | Human | elinzanetant | elinzanetant | EMEA/H/C/006298 | Bayer AG | 2025/11/17 | Authorised |
| Usgena | Human | ustekinumab | ustekinumab | EMEA/H/C/006667 | Stada Arzneimittel AG | 2025/11/17 | Authorised |
| Gobivaz | Human | golimumab | golimumab | EMEA/H/C/006560 | Advanz Pharma Limited | 2025/11/17 | Authorised |
| Winlevi | Human | clascoterone | clascoterone | EMEA/H/C/006138 | Cassiopea S.p.A. | 2025/10/17 | Authorised |
| Kisunla | Human | donanemab | donanemab | EMEA/H/C/006024 | Eli Lilly Nederland B.V. | 2025/09/24 | Authorised |
| Macitentan AccordPharma | Human | macitentan | macitentan | EMEA/H/C/006523 | Accord Healthcare | 2025/09/24 | Authorised |
| Macitentan Accord | Human | macitentan | macitentan | EMEA/H/C/006524 | Accord Healthcare | 2025/09/24 | Authorised |
| Voranigo | Human | vorasidenib | vorasidenib | EMEA/H/C/006284 | Les Laboratoires Servier | 2025/09/17 | Authorised |
| Usrenty | Human | ustekinumab | ustekinumab | EMEA/H/C/006794 | Biosimilar Collaborations Ireland Limited | 2025/09/17 | Authorised |
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