欧盟上市药品（最近更新）
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| 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 |
|---|---|---|---|---|---|---|---|---|---|
| etranacogene dezaparvovec | etranacogene dezaparvovec | Hemgenix | CSL Behring GmbH | Authorised | 2023-02-20 | 2026-08-27 | EMEA/H/C/004827 | Hemophilia B | Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors. |
| adalimumab | adalimumab | Hulio | Biosimilar Collaborations Ireland Limited | Authorised | 2018-09-17 | 2026-08-27 | EMEA/H/C/004429 | Hidradenitis Suppurativa、Psoriasis、Uveitis、Arthritis, Rheumatoid、Spondylitis, Ankylosing、Crohn Disease、Colitis, Ulcerative、Arthritis, Psoriatic | Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisHulio 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). Hulio 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 arthritisHulio 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).Paediatric plaque psoriasisHulio 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.Paediatric Crohn's diseaseHulio 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.Paediatric UveitisHulio 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. |
| tafamidis | tafamidis | Vyndaqel | Pfizer Europe MA EEIG | Authorised | 2011-11-16 | 2026-08-27 | EMEA/H/C/002294 | Amyloidosis | Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment. |
| semaglutide | semaglutide | Wegovy | Novo Nordisk A/S | Authorised | 2022-01-06 | 2026-08-26 | EMEA/H/C/005422 | Obesity、Overweight | AdultsWegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of≥30 kg/m2 (obesity), or≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1.Adolescents (≥12 years)Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above withobesity* andbody weight above 60 kg.Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.*Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC).Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria) |
| alpelisib | Alpelisib | Vijoice | Novartis Europharm Limited | Application withdrawn | 2026-07-15 | 2026-08-26 | EMEA/H/C/006539 | Genetic Diseases, Inborn、Growth Disorders | Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) |
| dexamethasone | dexamethasone | Neofordex | THERAVIA | Authorised | 2016-03-16 | 2026-08-26 | EMEA/H/C/004071 | Multiple Myeloma | Treatment of multiple myeloma. |
| COVID-19 mRNA vaccine (nucleoside-modified) | Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 | Comirnaty | BioNTech Manufacturing GmbH | Authorised | 2020-12-21 | 2026-08-26 | EMEA/H/C/005735 | COVID-19 virus infection | Comirnaty JN.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Comirnaty JN.1 concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in infants and children aged 6 months to 11 years. The use of this vaccine should be in accordance with official recommendations.Comirnaty KP.2 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Comirnaty XFG dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. |
| COVID-19 mRNA Vaccine (nucleoside modified) | CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2) | Spikevax (previously COVID-19 Vaccine Moderna) | Moderna Biotech Spain, S.L. | Authorised | 2021-01-06 | 2026-08-26 | EMEA/H/C/005791 | COVID-19 virus infection | Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. The use of this vaccine should be in accordance with official recommendations.Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Spikevax LP.8.1 is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.Spikevax XFG is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. |
| semaglutide | semaglutide | Ozempic | Novo Nordisk A/S | Authorised | 2018-02-08 | 2026-08-25 | EMEA/H/C/004174 | Diabetes Mellitus | Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. |
| human hepatitis B immunoglobulin | human hepatitis B immunoglobulin | Zutectra | Biotest Pharma GmbH | Authorised | 2009-11-30 | 2026-08-25 | EMEA/H/C/001089 | Immunization, Passive、Hepatitis B、Liver Transplantation | Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start.The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis. |
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