| 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 |
|---|---|---|---|---|---|---|---|
| Pluvicto | Human | lutetium (177Lu) vipivotide tetraxetan | lutetium (177Lu) vipivotide tetraxetan | EMEA/H/C/005483 | Novartis Europharm Limited | 2022/12/09 | Authorised |
| Spevigo | Human | spesolimab | spesolimab | EMEA/H/C/005874 | LEO Pharma A/S | 2022/12/09 | Authorised |
| Locametz | Human | gozetotide | gozetotide | EMEA/H/C/005488 | Novartis Europharm Limited | 2022/12/09 | Authorised |
| Livmarli | Human | maralixibat chloride | Maralixibat chloride | EMEA/H/C/005857 | Mirum Pharmaceuticals International B.V. | 2022/12/09 | Authorised |
| Qdenga | Human | dengue tetravalent vaccine (live, attenuated) | Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated;Dengue virus, serotype 2, live, attenuated | EMEA/H/C/005155 | Takeda Pharmaceuticals International AG Ireland Branch | 2022/12/05 | Authorised |
| Mycapssa | Human | octreotide | octreotide acetate | EMEA/H/C/005826 | Amryt Pharmaceuticals DAC | 2022/12/02 | Withdrawn |
| Teriparatide Sun | Human | teriparatide | teriparatide | EMEA/H/C/005793 | Sun Pharmaceutical Industries Europe B.V. | 2022/11/18 | Authorised |
| Enjaymo | Human | sutimlimab | sutimlimab | EMEA/H/C/005776 | Recordati Rare Diseases | 2022/11/15 | Authorised |
| VidPrevtyn Beta | Human | COVID-19 Vaccine (recombinant, adjuvanted) | SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain) | EMEA/H/C/005754 | Sanofi Pasteur | 2022/11/10 | Withdrawn |
| Ximluci | Human | ranibizumab | ranibizumab | EMEA/H/C/005617 | STADA Arzneimittel AG | 2022/11/09 | Authorised |
| Pyrukynd | Human | mitapivat | mitapivat sulfate | EMEA/H/C/005540 | Agios Netherlands B.V. | 2022/11/09 | Authorised |
| Teriflunomide Accord | Human | teriflunomide | teriflunomide | EMEA/H/C/005960 | Accord Healthcare S.L.U. | 2022/11/09 | Authorised |
| Teriflunomide Viatris (previously Teriflunomide Mylan) | Human | teriflunomide | teriflunomide | EMEA/H/C/005962 | Viatris Limited | 2022/11/09 | Authorised |
| Livtencity | Human | maribavir | Maribavir | EMEA/H/C/005787 | Takeda Pharmaceuticals International AG Ireland Branch | 2022/11/09 | Authorised |
| Sorafenib Accord | Human | sorafenib | sorafenib tosilate | EMEA/H/C/005921 | Accord Healthcare S.L.U. | 2022/11/09 | Authorised |
| Melatonin Neurim | Human | melatonin | melatonin | EMEA/H/C/005603 | RAD Neurim Pharmaceuticals EEC SARL | 2022/11/07 | Authorised |
| Beyfortus | Human | nirsevimab | nirsevimab | EMEA/H/C/005304 | Sanofi Winthrop Industrie | 2022/10/31 | Authorised |
| Tezspire | Human | tezepelumab | tezepelumab | EMEA/H/C/005588 | AstraZeneca AB | 2022/09/19 | Authorised |
| Thalidomide Lipomed | Human | thalidomide | thalidomide | EMEA/H/C/005715 | Lipomed GmbH | 2022/09/19 | Authorised |
| Nulibry | Human | fosdenopterin | fosdenopterin hydrobromide dihydrate | EMEA/H/C/005378 | TMC Pharma (EU) Limited | 2022/09/15 | Authorised |
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