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 |
|---|---|---|---|---|---|---|---|---|---|
| berotralstat | berotralstat dihydrochloride | Orladeyo | Neopharmed Gentili Ireland Limited | Authorised | 2021-04-30 | 2026-10-06 | EMEA/H/C/005138 | Angioedemas, Hereditary | Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older weighing at least 40 kg.Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in:children aged 2 to less than 12 years weighing at least 15 kgadolescents aged 12 and older weighing less than 40 kg |
| birch bark extract | dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) | Filsuvez | Chiesi Farmaceutici S.p.A | Authorised | 2022-06-21 | 2026-10-06 | EMEA/H/C/005035 | Epidermolysis Bullosa Dystrophica、Epidermolysis Bullosa, Junctional | Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older. |
| telmisartan | Telmisartan | Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) | Bayer AG | Authorised | 1998-12-16 | 2026-10-06 | EMEA/H/C/000211 | Hypertension | HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage. |
| ustekinumab | ustekinumab | Steqeyma | Celltrion Healthcare Hungary Kft. | Authorised | 2024-08-22 | 2026-10-06 | EMEA/H/C/005918 | Psoriasis、Arthritis, Psoriatic、Crohn Disease | Plaque psoriasisSteqeyma is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).Paediatric plaque psoriasisSteqeyma is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritis (PsA)Steqeyma alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.Adult Crohn’s DiseaseSteqeyma is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.Paediatric Crohn's DiseaseSteqeyma is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Ulcerative colitisSteqeyma is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. |
| ustekinumab | ustekinumab | Usymro | Gedeon Richter Plc. | Authorised | 2025-08-14 | 2026-10-06 | EMEA/H/C/006467 | Crohn Disease、Psoriasis、Arthritis, Psoriatic | Plaque psoriasisUsymro is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).Paediatric plaque psoriasisUsymro is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritis (PsA)Usymro, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.Adult Crohn’s diseaseUsymro is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.Paediatric Crohn’s diseaseUsymro is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Ulcerative ColitisUsymro is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. |
| ertapenem | ertapenem sodium | Ertapenem SUN | SUN Pharmaceutical Industries (Europe) B.V. | Authorised | 2022-07-15 | 2026-10-05 | EMEA/H/C/005815 | Bacterial Infections | TreatmentErtapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):Intra-abdominal infectionsCommunity acquired pneumoniaAcute gynaecological infectionsDiabetic foot infections of the skin and soft tissue (see section 4.4)PreventionErtapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed) | filamentous haemagglutinin、Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate)、hepatitis B surface antigen、pertussis toxoid、poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells、poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells、poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells、tetanus protein、tetanus toxoid adsorbed on aluminium hydroxide, hydrated、Diphtheria toxoid | Hexyon | Sanofi Winthrop Industrie | Authorised | 2013-04-17 | 2026-10-05 | EMEA/H/C/002796 | Hepatitis B、Tetanus、Immunization、Meningitis, Haemophilus、Whooping Cough、Poliomyelitis、Diphtheria | Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).The use of this vaccine should be in accordance with official recommendations. |
| erenumab | erenumab | Aimovig | Novartis Europharm Limited | Authorised | 2018-07-26 | 2026-10-05 | EMEA/H/C/004447 | Migraine Disorders | Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig. |
| ranibizumab | ranibizumab | Byooviz | Samsung Bioepis NL B.V. | Authorised | 2021-08-18 | 2026-10-05 | EMEA/H/C/005545 | Wet Macular Degeneration、Macular Edema、Diabetic Retinopathy、Myopia, Degenerative | Byooviz is indicated in adults for:The treatment of neovascular (wet) age-related macular degeneration (AMD)The treatment of visual impairment due to diabetic macular oedema (DME)The treatment of proliferative diabetic retinopathy (PDR)The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)The treatment of visual impairment due to choroidal neovascularisation (CNV) |
| telmisartan、hydrochlorothiazide | telmisartan、hydrochlorothiazide | PritorPlus | Bayer AG | Authorised | 2002-04-22 | 2026-10-05 | EMEA/H/C/000414 | Hypertension | Treatment of essential hypertension.PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately. |