欧盟上市药品（最近更新）
按更新时间最近更新
| 药品名称 | 活性成分 | 商品名 | 生产企业 | 审评状态 | 批准日期 | 更新日期 | 产品编号 | 治疗领域 | 适应症 |
|---|---|---|---|---|---|---|---|---|---|
| abemaciclib | abemaciclib | Verzenios | Eli Lilly Nederland B.V. | Authorised | 2018-09-26 | 2026-08-25 | EMEA/H/C/004302 | Breast Neoplasms | Early Breast CancerVerzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1).In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.Advanced or Metastatic Breast CancerVerzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. |
| netupitant、palonosetron | netupitant、palonosetron hydrochloride | Akynzeo | Helsinn Birex Pharmaceuticals Ltd | Authorised | 2015-05-27 | 2026-08-25 | EMEA/H/C/003728 | Vomiting、Neoplasms、Nausea、Cancer | Akynzeo is indicated in adults for the:Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy. |
| rotavirus vaccine, live, attenuated | human rotavirus, live attenuated | Rotarix | GlaxoSmithKline Biologicals S.A. | Authorised | 2006-02-21 | 2026-08-24 | EMEA/H/C/000639 | Immunization、Rotavirus Infections | Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection.The use of Rotarix should be based on official recommendation. |
| adalimumab | adalimumab | Yuflyma | Celltrion Healthcare Hungary Kft. | Authorised | 2021-02-11 | 2026-08-24 | EMEA/H/C/005188 | Arthritis, Rheumatoid、Arthritis, Psoriatic、Psoriasis、Spondylitis, Ankylosing、Uveitis、Hidradenitis Suppurativa、Colitis, Ulcerative、Crohn Disease、Arthritis, Juvenile Rheumatoid | Rheumatoid arthritisYuflyma in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisYuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.Enthesitis-related arthritisYuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).Axial spondyloarthritisAnkylosing spondylitis (AS)Yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Axial spondyloarthritis without radiographic evidence of ASYuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).Psoriatic arthritisYuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.PsoriasisYuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Paediatric plaque psoriasisYuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.Hidradenitis suppurativa (HS)Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).Crohn’s diseaseYuflyma is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.Paediatric Crohn's diseaseYuflyma is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.Ulcerative colitisYuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Paediatric ulcerative colitisYuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.UveitisYuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.Paediatric uveitisYuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. |
| chenodeoxycholic acid | Chenodeoxycholic acid | Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) | Leadiant Biosciences Ireland Limited | Authorised | 2017-04-10 | 2026-08-24 | EMEA/H/C/004061 | Xanthomatosis, Cerebrotendinous、Metabolism, Inborn Errors | Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults. |
| denosumab | denosumab | Bomyntra | Fresenius Kabi Deutschland GmbH | Authorised | 2025-07-17 | 2026-08-24 | EMEA/H/C/006269 | Neoplasms, Bone Tissue、Giant Cell Tumor of Bone | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. |
| denosumab | denosumab | Izamby | Mabxience Research SL | Authorised | 2025-06-26 | 2026-08-24 | EMEA/H/C/006152 | Bone Resorption、Osteoporosis、Osteoporosis, Postmenopausal | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Izamby significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). |
| chenodeoxycholic acid | Chenodeoxycholic acid | Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) | Leadiant Biosciences Ireland Limited | Authorised | 2017-04-10 | 2026-08-24 | EMEA/H/C/004061 | Xanthomatosis, Cerebrotendinous、Metabolism, Inborn Errors | Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults. |
| Chikungunya vaccine (live) | Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated | Ixchiq | Valneva Austria GmbH | Authorised | 2024-06-28 | 2026-08-24 | EMEA/H/C/005797 | Chikungunya virus | Ixchiq is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older at high risk of acquiring chikungunya infection. The use of this vaccine should be in accordance with official recommendations. |
| faricimab | Faricimab | Vabysmo | Roche Registration GmbH | Authorised | 2022-09-15 | 2026-08-21 | EMEA/H/C/005642 | Wet Macular Degeneration、Macular Edema、Diabetes Complications | Vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (nAMD),visual impairment due to diabetic macular oedema (DME),visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). |