| 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 |
|---|---|---|---|---|---|---|---|
| Fulphila | Human | pegfilgrastim | pegfilgrastim | EMEA/H/C/004915 | Biosimilar Collaborations Ireland Limited | 2018/11/20 | Authorised |
| Emgality | Human | galcanezumab | Galcanezumab | EMEA/H/C/004648 | Eli Lilly Nederland B.V. | 2018/11/14 | Authorised |
| Symkevi | Human | tezacaftor;ivacaftor | tezacaftor;ivacaftor | EMEA/H/C/004682 | Vertex Pharmaceuticals (Ireland) Limited | 2018/10/31 | Authorised |
| Gefitinib Mylan | Human | gefitinib | gefitinib | EMEA/H/C/004826 | Mylan Pharmaceuticals Limited | 2018/09/27 | Withdrawn |
| Verzenios | Human | abemaciclib | abemaciclib | EMEA/H/C/004302 | Eli Lilly Nederland B.V. | 2018/09/26 | Authorised |
| Imfinzi | Human | durvalumab | durvalumab | EMEA/H/C/004771 | AstraZeneca AB | 2018/09/21 | Authorised |
| Pelgraz | Human | pegfilgrastim | pegfilgrastim | EMEA/H/C/003961 | Accord Healthcare S.L.U. | 2018/09/21 | Authorised |
| Udenyca | Human | pegfilgrastim | pegfilgrastim | EMEA/H/C/004413 | ERA Consulting GmbH | 2018/09/21 | Withdrawn |
| Xerava | Human | eravacycline | eravacycline | EMEA/H/C/004237 | PAION Pharma GmbH | 2018/09/20 | Authorised |
| Slenyto | Human | melatonin | melatonin | EMEA/H/C/004425 | RAD Neurim Pharmaceuticals EEC SARL | 2018/09/20 | Authorised |
| Mektovi | Human | binimetinib | binimetinib | EMEA/H/C/004579 | Pierre Fabre Medicament | 2018/09/20 | Authorised |
| Kigabeq | Human | vigabatrin | vigabatrin | EMEA/H/C/004534 | ORPHELIA Pharma | 2018/09/20 | Authorised |
| Lenalidomide Accord | Human | lenalidomide | lenalidomide | EMEA/H/C/004857 | Accord Healthcare S.L.U. | 2018/09/20 | Authorised |
| Braftovi | Human | encorafenib | Encorafenib | EMEA/H/C/004580 | Pierre Fabre Medicament | 2018/09/19 | Authorised |
| Deferiprone Lipomed | Human | deferiprone | Deferiprone | EMEA/H/C/004710 | Lipomed GmbH | 2018/09/19 | Authorised |
| Ilumetri | Human | tildrakizumab | tildrakizumab | EMEA/H/C/004514 | Almirall, S.A. | 2018/09/17 | Authorised |
| Hulio | Human | adalimumab | adalimumab | EMEA/H/C/004429 | Biosimilar Collaborations Ireland Limited | 2018/09/17 | Authorised |
| Veyvondi | Human | vonicog alfa | vonicog alfa | EMEA/H/C/004454 | Baxalta Innovations GmbH | 2018/08/31 | Authorised |
| Nerlynx | Human | neratinib | neratinib | EMEA/H/C/004030 | Pierre Fabre Medicament | 2018/08/31 | Authorised |
| Cablivi | Human | caplacizumab | Caplacizumab | EMEA/H/C/004426 | Ablynx NV | 2018/08/30 | Authorised |
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