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 |
|---|---|---|---|---|---|---|---|---|---|
| piflufolastat (18F) | Piflufolastat (18F) | Pylclari | Curium Pet France | Authorised | 2023-11-27 | 2026-10-09 | EMEA/H/C/005520 | Prostatic Neoplasms | This medicinal product is for diagnostic use only.Pylclari is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:Primary staging of patients with high-risk PCa prior to initial curative therapy,To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent.Pylclari is indicated for use with positron emission tomography (PET). |
| ranibizumab | ranibizumab | Lucentis | Novartis Europharm Limited | Authorised | 2007-01-22 | 2026-10-08 | EMEA/H/C/000715 | Wet Macular Degeneration、Macular Edema、Diabetes Complications、Myopia, Degenerative、Choroidal Neovascularization | Lucentis is indicated in adults for:The treatment of neovascular (wet) age-related macular degeneration (AMD)The treatment of visual impairment due to choroidal neovascularisation (CNV)The treatment of visual impairment due to diabetic macular oedema (DME)The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) |
| mecasermin | Mecasermin | Increlex | Esteve Pharmaceuticals, S.A. | Authorised | 2007-08-02 | 2026-10-08 | EMEA/H/C/000704 | Laron Syndrome | For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD).Severe primary IGFD is defined by:height standard deviation score ? -3.0 and;basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and;growth hormone (GH) sufficiency;exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test. |
| acalabrutinib | Acalabrutinib | Calquence | AstraZeneca AB | Authorised | 2020-11-05 | 2026-10-07 | EMEA/H/C/005299 | Leukemia, Lymphocytic, Chronic, B-Cell | Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor. |
| ritonavir | ritonavir | Ritonavir Viatris (previously Ritonavir Mylan) | Viatris Limited | Authorised | 2017-11-09 | 2026-10-07 | EMEA/H/C/004549 | HIV Infections | Ritonavir is indicated as a pharmacokinetic enhancer of co-administered protease inhibitors as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected patients (adults and children of 2 years of age and older). |
| ibrutinib | Ibrutinib | Imbruvica | Janssen-Cilag International NV | Authorised | 2014-10-21 | 2026-10-07 | EMEA/H/C/003791 | Lymphoma, Mantle-Cell、Leukemia, Lymphocytic, Chronic, B-Cell | Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM. |
| abrocitinib | Abrocitinib | Cibinqo | Pfizer Europe MA EEIG | Authorised | 2021-12-09 | 2026-10-07 | EMEA/H/C/005452 | Dermatitis, Atopic | Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. |
| rituximab | rituximab | Ruxience | Pfizer Europe MA EEIG | Authorised | 2020-04-01 | 2026-10-06 | EMEA/H/C/004696 | Leukemia, Lymphocytic, Chronic, B-Cell、Arthritis, Rheumatoid、Microscopic Polyangiitis、Pemphigus | Ruxience is indicated in adults for the following indications:Non?Hodgkin’s lymphoma (NHL)Ruxience is indicated for the treatment of previously untreated patients with stage III?IV follicular lymphoma in combination with chemotherapy.Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Ruxience monotherapy is indicated for treatment of patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.Ruxience is indicated for the treatment of patients with CD20 positive diffuse large B cell non?Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.Chronic lymphocytic leukaemia (CLL)Ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.Rheumatoid arthritisRuxience in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease?modifying anti?rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.Ruxience 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.Granulomatosis with polyangiitis and microscopic polyangiitisRuxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).Pemphigus vulgarisRuxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV). |
| resminostat | resminostat mesilate | Kinselby | 4Sc AG | Opinion | — | 2026-10-06 | EMEA/H/C/006259 | Mycosis Fungoides、Sezary Syndrome | — |
| metreleptin | Metreleptin | Myalepta | Chiesi Farmaceutici S.p.A. | Authorised | 2018-07-30 | 2026-10-06 | EMEA/H/C/004218 | Lipodystrophy, Familial Partial | Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and abovewith confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. |
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