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 |
|---|---|---|---|---|---|---|---|---|---|
| Tofersen | Tofersen | Qalsody | Biogen Netherlands B.V. | Authorised | 2024-05-29 | 2026-10-13 | EMEA/H/C/005493 | Amyotrophic Lateral Sclerosis | Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. |
| fingolimod | fingolimod hydrochloride | Fingolimod Accord | Accord Healthcare S.L.U. | Authorised | 2020-06-25 | 2026-10-13 | EMEA/H/C/005191 | Multiple Sclerosis, Relapsing-Remitting | Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapyorPatients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. |
| sildenafil | sildenafil | Viagra | Viatris EESV | Authorised | 1998-09-13 | 2026-10-13 | EMEA/H/C/000202 | Erectile Dysfunction | Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Viagra to be effective, sexual stimulation is required. |
| sunitinib | sunitinib | Sunitinib Accord | Accord Healthcare S.L.U. | Authorised | 2021-02-11 | 2026-10-12 | EMEA/H/C/005419 | Gastrointestinal Stromal Tumors、Carcinoma, Renal Cell、Neuroendocrine Tumors | Gastrointestinal stromal tumour (GIST)Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.Metastatic renal cell carcinoma (MRCC)Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET)Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. |
| nintedanib | nintedanib | Ofev | Boehringer Ingelheim International GmbH | Authorised | 2015-01-14 | 2026-10-12 | EMEA/H/C/003821 | Idiopathic Pulmonary Fibrosis、Lung Diseases, Interstitial、Pulmonary Fibrosis、Scleroderma, Systemic | Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF). |
| netarsudil | Netarsudil | Rhokiinsa | Santen Oy | Authorised | 2019-11-19 | 2026-10-12 | EMEA/H/C/004583 | Glaucoma, Open-Angle、Ocular Hypertension | Reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension. |
| Exagamglogene autotemcel | Exagamglogene autotemcel | Casgevy | Vertex Pharmaceuticals (Ireland) Limited | Authorised | 2024-02-09 | 2026-10-12 | EMEA/H/C/005763 | beta-Thalassemia、Anemia, Sickle Cell | β thalassemiaCasgevy is indicated for the treatment of transfusion dependent β thalassemia (TDT) in patients 12 years of age and older for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available.Sickle cell diseaseCasgevy is indicated for the treatment of severe sickle cell disease (SCD) in patients 12 years of age and older with recurrent vaso occlusive crises (VOCs) for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available. |
| lazertinib | lazertinib mesilate monohydrate | Lazcluze | Janssen Cilag International NV | Authorised | 2025-01-20 | 2026-10-12 | EMEA/H/C/006074 | Carcinoma, Non-Small-Cell Lung | Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. |
| efanesoctocog alfa | Efanesoctocog alfa | Altuvoct | Swedish Orphan Biovitrum AB (publ) | Authorised | 2024-06-17 | 2026-10-12 | EMEA/H/C/005968 | Hemophilia A | Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Altuvoct can be used for all age groups. |
| 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). |