Hympavzi |
marstacimab | 马塔西单抗 | B02BX11 | 2024-11-18 | Pfizer Europe MA EEIG | Authorised |
Absimky |
ustekinumab | 乌司奴单抗 | L04AC05 | 2024-12-12 | Accord Healthcare S.L.U. | Authorised |
Alhemo |
concizumab | 康赛珠单抗 | B02BX10 | | Novo Nordisk A/S | Opinion |
Buprenorphine Neuraxpharm |
buprenorphine | 盐酸丁丙诺啡 | N07BC01 | | Neuraxpharm Pharmaceuticals S.L. | Opinion |
Fluad |
influenza vaccine (surface antigen, inactivated, adjuvanted) | | J07BB02 | 2024-11-15 | Seqirus Netherlands B.V. | Authorised |
Flucelvax |
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) | | J07BB02 | 2024-11-15 | Seqirus Netherlands B.V. | Authorised |
Siiltibcy |
Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10) | | | | Serum Life Science Europe GmbH | Opinion |
Imuldosa |
ustekinumab | 乌司奴单抗 | L04AC05 | 2024-12-12 | Accord Healthcare S.L.U. | Authorised |
Epixram |
levetiracetam | | N03AX14 | | Neuraxpharm Pharmaceuticals S.L. | Application withdrawn |
Apremilast Viatris |
apremilast | 阿普米司特 | L04AA32 | | Viatris Limited | Application withdrawn |
Korjuny |
catumaxomab | 卡妥索单抗 | L01XC09 | | Lindis Biotech GmbH | Opinion |
Eltrombopag Viatris |
eltrombopag | 艾曲泊帕乙醇胺 | B02BX05 | | Viatris Limited | Opinion |
Wainzua |
eplontersen | | N07XX21 | | AstraZeneca AB | Opinion |
Hetronifly |
serplulimab | 斯鲁利单抗 | L01FF12 | | Henlius Europe GmbH | Opinion |
Pomalidomide Teva |
pomalidomide | 泊马度胺 | L04AX06 | 2024-11-14 | Teva GmbH | Authorised |
Opuviz |
aflibercept | 阿柏西普 | S01LA05 | 2024-11-13 | Samsung Bioepis NL B.V. | Authorised |
Afqlir |
aflibercept | 阿柏西普 | S01LA05 | | Sandoz GmbH | Opinion |
Penbraya |
Meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed) | | J07AH11 | 2024-11-14 | Pfizer Europe MA EEIG | Authorised |
Theralugand |
lutetium (177Lu) chloride | 氯化镥[177Lu] | V10X | 2024-11-22 | Eckert & Ziegler Radiopharma GmbH | Authorised |
Elahere |
mirvetuximab soravtansine | 索米妥昔单抗 | L01FX26 | 2024-11-14 | AbbVie Deutschland GmbH & Co. KG | Authorised |