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
imlifidase	Imlifidase	Idefirix	SERB SA	Authorised	2020-08-25	2026-10-16	EMEA/H/C/004849	Desensitization, Immunologic、Kidney Transplantation	Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
enfortumab vedotin	Enfortumab vedotin	Padcev	Astellas Pharma Europe B.V.	Authorised	2022-04-13	2026-10-16	EMEA/H/C/005392	Carcinoma, Transitional Cell、Urologic Neoplasms	Muscle invasive bladder cancer (MIBC)Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).Unresectable or metastatic urothelial cancerPadcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.Locally advanced or metastatic urothelial cancerPadcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor‑1 or programmed death‑ligand 1 inhibitor (see section 5.1).
cabozantinib	cabozantinib (s)-malate	Cabometyx	Ipsen Pharma	Authorised	2016-09-09	2026-10-15	EMEA/H/C/004163	Carcinoma, Renal Cell、Carcinomas, Hepatocellular	Renal Cell Carcinoma (RCC)Cabometyx is indicated as monotherapy for advanced renal cell carcinomaas first-line treatment of adult patients with intermediate or poor risk,in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
idursulfase	idursulfase	Elaprase	Takeda Pharmaceuticals International AG Ireland Branch	Authorised	2007-01-08	2026-10-15	EMEA/H/C/000700	Mucopolysaccharidosis II	Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
tenofovir disoproxil	tenofovir disoproxil	Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)	Viatris Limited	Authorised	2016-12-08	2026-10-14	EMEA/H/C/004049	HIV Infections	HIV-1 infectionTenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).Tenofovir disoproxil 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.The choice of tenofovir disoproxil to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infectionTenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.evidence of lamivudine-resistant hepatitis B virus.decompensated liver disease.Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
follitropin alfa	follitropin alfa	Bemfola	Gedeon Richter Plc.	Authorised	2014-03-26	2026-10-13	EMEA/H/C/002615	Anovulation	In adult women:anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such asin vitrofertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT);follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.In adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
guanfacine	guanfacine hydrochloride	Intuniv	Takeda Pharmaceuticals International AG Ireland	Authorised	2015-09-17	2026-10-13	EMEA/H/C/003759	Attention Deficit Disorder with Hyperactivity	Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
pregabalin	pregabalin	Lyrica	Viatris EESV	Authorised	2004-07-05	2026-10-13	EMEA/H/C/000546	Epilepsy、Anxiety Disorders、Neuralgia	Neuropathic painLyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyLyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderLyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
baricitinib	baricitinib	Olumiant	Eli Lilly Nederland B.V.	Authorised	2017-02-13	2026-10-13	EMEA/H/C/004085	Arthritis, Rheumatoid	Rheumatoid arthritisBaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisOlumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.Alopecia areataBaricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older.Juvenile idiopathic arthritisBaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),Enthesitis related arthritis, andJuvenile psoriatic arthritis.Baricitinib may be used as monotherapy or in combination with methotrexate.
sildenafil	sildenafil	Revatio	Viatris EESV	Authorised	2005-10-28	2026-10-13	EMEA/H/C/000638	Hypertension, Pulmonary	Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.Paediatric populationTreatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

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