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 |
---|---|---|---|---|---|---|---|
Dyrupeg | Human | pegfilgrastim | pegfilgrastim | EMEA/H/C/006407 | CuraTeQ Biologics s.r.o | 2025/03/28 | Authorised |
Tivdak | Human | tisotumab vedotin | tisotumab vedotin | EMEA/H/C/005363 | Pfizer Europe MA EEIG | 2025/03/28 | Authorised |
Capvaxive | Human | pneumococcal polysaccharide conjugate vaccine (21-valent) | pneumococcal polysaccharide serotype 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B conjugated to CRM197 carrier protein | EMEA/H/C/006267 | Merck Sharp & Dohme B.V. | 2025/03/24 | Authorised |
Rytelo | Human | imetelstat | imetelstat | EMEA/H/C/006105 | Geron Netherlands B.V. | 2025/03/07 | Authorised |
Wainzua | Human | eplontersen | eplontersen sodium | EMEA/H/C/006295 | AstraZeneca AB | 2025/03/06 | Authorised |
Vimkunya | Human | Chikungunya vaccine (recombinant, adsorbed) | Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated | EMEA/H/C/005470 | Bavarian Nordic A/S | 2025/02/28 | Authorised |
Paxneury | Human | guanfacine | guanfacine hydrochloride | EMEA/H/C/006312 | Neuraxpharm Pharmaceuticals S.L. | 2025/02/26 | Authorised |
Avtozma | Human | tocilizumab | tocilizumab | EMEA/H/C/006196 | Celltrion Healthcare Hungary Kft. | 2025/02/14 | Authorised |
Stoboclo | Human | denosumab | denosumab | EMEA/H/C/006156 | Celltrion Healthcare Hungary Kft. | 2025/02/14 | Authorised |
Osenvelt | Human | denosumab | denosumab | EMEA/H/C/006157 | Celltrion Healthcare Hungary Kft. | 2025/02/14 | Authorised |
Yesintek | Human | ustekinumab | ustekinumab | EMEA/H/C/006444 | Biosimilar Collaborations Ireland Limited | 2025/02/14 | Authorised |
Zefylti | Human | filgrastim | filgrastim | EMEA/H/C/006400 | CuraTeQ Biologics s.r.o | 2025/02/12 | Authorised |
Eydenzelt | Human | aflibercept | aflibercept | EMEA/H/C/005899 | Celltrion Healthcare Hungary Kft. | 2025/02/12 | Authorised |
Emcitate | Human | tiratricol | tiratricol | EMEA/H/C/005220 | Rare Thyroid Therapeutics International AB | 2025/02/12 | Authorised |
Obodence | Human | denosumab | denosumab | EMEA/H/C/006424 | Samsung Bioepis NL B.V. | 2025/02/12 | Authorised |
Nemluvio | Human | nemolizumab | nemolizumab | EMEA/H/C/006149 | Galderma International | 2025/02/12 | Authorised |
Korjuny | Human | catumaxomab | catumaxomab | EMEA/H/C/005697 | Lindis Biotech GmbH | 2025/02/10 | Authorised |
Andembry | Human | garadacimab | garadacimab | EMEA/H/C/006116 | CSL Behring GmbH | 2025/02/10 | Authorised |
Beyonttra | Human | acoramidis | acoramidis hydrochloride | EMEA/H/C/006333 | BridgeBio Europe B.V. | 2025/02/10 | Authorised |
Hetronifly | Human | serplulimab | Serplulimab | EMEA/H/C/006170 | Accord Healthcare S.L.U. | 2025/02/03 | Authorised |