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 |
|---|---|---|---|---|---|---|---|---|---|
| telmisartan、hydrochlorothiazide | telmisartan、hydrochlorothiazide | Kinzalkomb | Bayer AG | Authorised | 2002-04-19 | 2026-10-05 | EMEA/H/C/000415 | Hypertension | Treatment of essential hypertension.Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately. |
| exenatide | exenatide | Bydureon | AstraZeneca AB | Authorised | 2011-06-17 | 2026-10-02 | EMEA/H/C/002020 | Diabetes Mellitus, Type 2 | Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations).Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with:MetforminSulphonylureaThiazolidinedioneMetformin and sulphonylureaMetformin and thiazolidinedionein adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. |
| pegfilgrastim | pegfilgrastim | Ziextenzo | Sandoz GmbH | Authorised | 2018-11-22 | 2026-10-02 | EMEA/H/C/004802 | — | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). |
| glycopyrronium | glycopyrronium bromide | Sialanar | Proveca Pharma Limited | Authorised | 2016-09-15 | 2026-10-02 | EMEA/H/C/003883 | Sialorrhea | Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. |
| arsenic trioxide | Arsenic trioxide | Arsenic trioxide Accord | Accord Healthcare S.L.U. | Authorised | 2019-11-14 | 2026-10-02 | EMEA/H/C/005175 | Leukemia, Promyelocytic, Acute | Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all-trans-retinoic acid (ATRA)Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined. |
| formoterol fumarate dihydrate、glycopyrronium、budesonide | budesonide、formoterol fumarate dihydrate、glycopyrronium bromide | Riltrava Aerosphere | AstraZeneca AB | Authorised | 2022-01-06 | 2026-10-02 | EMEA/H/C/005311 | Pulmonary Disease, Chronic Obstructive | Riltrava Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long acting beta2 agonist.Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist. |
| relugolix | Relugolix | Orgovyx | Accord Healthcare S.L.U. | Authorised | 2022-04-29 | 2026-10-02 | EMEA/H/C/005353 | Prostatic Neoplasms | Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. |
| Odronextamab | Odronextamab | Ordspono | Regeneron Ireland Designated Activity Company (DAC) | Authorised | 2024-08-22 | 2026-10-02 | EMEA/H/C/006215 | Lymphoma, Follicular | Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy. |
| ustekinumab | ustekinumab | Fymskina | Formycon AG | Authorised | 2024-09-25 | 2026-10-02 | EMEA/H/C/005805 | Crohn Disease、Psoriasis、Arthritis, Psoriatic | Adult Crohn’s DiseaseFymskina 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 DiseaseFymskina 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.Plaque psoriasisFymskina 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 psoriasisFymskina is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritis (PsA)Fymskina, 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. |
| garadacimab | garadacimab | Andembry | CSL Behring GmbH | Authorised | 2025-02-10 | 2026-10-02 | EMEA/H/C/006116 | Angioedemas, Hereditary | Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. |
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