EMA approvals 2026
Human medicines granted an EU marketing authorisation through EMA in 2026 (date of the European Commission decision), with the designations EMA publishes for each. From EMA's medicine data export; each entry links to its EPAR. EMA's annual figures count CHMP opinions and new active substances, so they differ from this list.
65 authorisations · 14 Orphan · 2 PRIME · 6 Conditional · 13 Biosimilar · 4 Generic or hybrid · EMA data as of Oct 14, 2026.
Nezglyal (leriglitazone)
Adrenoleukodystrophy. Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non Gadolinium (Gd) enhancing lesions (i.e. …
Icotyde (icotrokinra hydrochloride)
Psoriasis. Icotyde is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg, who are candidates for systemic therapy
Ruxolitinib Viatris (ruxolitinib hemifumarate)
Primary Myelofibrosis, Polycythemia Vera, Graft vs Host Disease. Myelofibrosis (MF) Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post …
Susvimo (ranibizumab)
Wet Macular Degeneration. Susvimo is indicated in adult patients for the treatment of neovascular (wet) age-related macular degeneration (nAMD) who have achieved stable disease after previously responding to intravitreal treatment with a vascular endothelial growth factor (VEGF) …
Tafamidis Accord (tafamidis)
Amyloidosis, Familial, Cardiomyopathies. Tafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRh-CM).
Zokovea (ensitrelvir fumaric acid)
COVID-19 virus infection. Post exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older
Denosumab Ascend (denosumab)
Neoplasms, Bone Tissue, Giant Cell Tumor of Bone. Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of …
Aujemflu (A/(H1N1)-like virus antigen;A/(H3N2)-like virus antigen;B (Victoria lineage)-like virus antigen)
Influenza, Human. Prophylaxis of influenza in adults 50 years of age and older. Aujemflu should be used in accordance with official recommendations.
Daybu (trofinetide)
Rett Syndrome. Daybu is indicated for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged 5 years and older.
Hopledo (carbidopa monohydrate;levodopa)
Parkinson Disease. Hopledo is indicated for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens.
Colchicine Agepha Pharma (colchicine)
Myocardial Infarction, Stroke, Coronary Artery Disease. Colchicine AGEPHA Pharma is indicated for secondary prevention of atherothrombotic events in adult patients with coronary disease stable for at least 6 months.
Etcamah (camizestrant)
Breast Neoplasms. Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without …
Ablymico (liraglutide)
Obesity, Overweight. Treatment of weight management.
Boey (trenibotulinumtoxinE)
Stress, Psychological, Cosmetic Techniques. Boey is indicated for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown (glabellar lines), when these have an important psychological impact in adult patients.
Jascayd (nerandomilast)
Idiopathic Pulmonary Fibrosis. Jascayd is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF). Jascayd is indicated for the treatment of adult patients with Progressive Pulmonary Fibrosis (PPF).
Liraglutide STADA (liraglutide)
Diabetes Mellitus. Treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise
Vijoice (alpelisib)
Genetic Diseases, Inborn, Growth Disorders. Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS)
Vislyfa (ranibizumab)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Vislyfa 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 …
Itvisma (onasemnogene abeparvovec)
Muscular Atrophy, Spinal. Itvisma is indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years of age and older.
Cenrifki (tolebrutinib)
Multiple Sclerosis, Chronic Progressive. Cenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
Palbociclib Viatris (Palbociclib)
Breast Neoplasms. Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. …
Redemplo (plozasiran sodium)
Hyperlipoproteinemia Type I. Redemplo is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS) (see section 4.2 for patient selection criteria).
Rexatilux (ranibizumab)
Wet Macular Degeneration. Rexatilux 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 …
Bopediat (furosemide)
Edema, Cardiac, Edema, Hypertension, Renal Insufficiency, Chronic. Bopediat is indicated in children from birth to less than 18 years of age for the treatment of oedema of cardiac or renal origin, oedema of hepatic origin, and hypertension in patients with chronic kidney disease.
Imdylltra (tarlatamab)
Small Cell Lung Carcinoma. Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
Zepzelca (lurbinectedin)
Small Cell Lung Carcinoma. Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin …
Adstiladrin (nadofaragene firadenovec)
Non-Muscle Invasive Bladder Neoplasms. Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
Joenja (leniolisib phosphate)
Primary Immunodeficiency Diseases. Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.
Bysumlog (insulin lispro)
Diabetes Mellitus. For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Bysumlog is also indicated for the initial stabilisation of diabetes mellitus.
Dazparda (insulin aspart)
Diabetes Mellitus. Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Onerji (levodopa;carbidopa)
Parkinson Disease. Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.
Tuyory (tocilizumab)
Arthritis, Rheumatoid, Arthritis, Juvenile, Cytokine Release Syndrome, Giant Cell Arteritis, COVID-19 virus infection. Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for:- the treatment of severe, active and progressive RA in adults not previously treated with MTX.- the treatment of moderate to severe active RA in adult patients who …
Xolremdi (mavorixafor)
Primary Immunodeficiency Diseases. Xolremdi is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.
Zandoriah (teriparatide)
Osteoporosis, Osteoporosis, Postmenopausal. Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures …
Fubelv (etanercept)
Arthritis, Rheumatoid, Arthritis, Juvenile, Arthritis, Psoriatic, Axial Spondyloarthritis, Non-Radiographic Axial Spondyloarthritis, Spondylitis, Ankylosing, Psoriasis. Rheumatoid arthritisFubelv in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), …
Palsonify (paltusotine hydrochloride)
Acromegaly. Palsonify is indicated for the medical treatment of adult patients with acromegaly.
Poherdy (pertuzumab)
Breast Neoplasms. Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence- the …
Rhapsido (remibrutinib)
Urticaria. Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
mCombriax (single-stranded, 5’-capped messenger RNAs (mRNAs) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding seasonal influenza haemagglutinin (HA) glycoproteins: A/H1N1, A/H3N2, B/Victoria)
Influenza, Human, COVID-19 virus infection. mCombriax is indicated for active immunisation for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Ojemda (tovorafenib)
Glioma. Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies …
Enflonsia (clesrovimab)
Respiratory Syncytial Virus Vaccines. Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.Enflonsia should be used in accordance with official recommendations.
Supemtek (A/California/07/2009 (H1N1)pdm09-like strain (A/California/07/2009);A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012);B/Brisbane/60/2008-like strain (B/Brisbane/60/2008))
Influenza, Human. Supemtek is indicated for active immunisation for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek should be used in accordance with official recommendations.
Fylrevy (estetrol monohydrate)
Menopause. Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal womenHormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last …
Ilumira (lutetium (177Lu) chloride)
Radionuclide Imaging. Ilumira is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) …
Kayshild (semaglutide)
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis. Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Kygevvi (doxecitine;Doxribtimine)
Mitochondrial Diseases. Kygevvi is indicated for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.
Rezurock (belumosudil mesilate)
Graft vs Host Disease. Rezurock is indicated for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable, …
Anktiva (nogapendekin alfa inbakicept)
Non-Muscle Invasive Bladder Neoplasms. Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
Aumseqa (Aumolertinib mesilate)
Carcinoma, Non-Small-Cell Lung. Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see …
Exdensur (depemokimab)
Asthma, Nasal Polyps. Asthma Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled …
mNexspike (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding the N-terminal domain and receptor-binding domain of the viral spike (S) protein of SARS-CoV-2)
COVID-19 virus infection. mNEXSPIKE is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Myqorzo (aficamten)
Cardiomyopathy, Hypertrophic. Myqorzo is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
Gotenfia (golimumab)
Arthritis, Rheumatoid, Arthritis, Juvenile, Arthritis, Psoriatic, Axial Spondyloarthritis, Non-Radiographic Axial Spondyloarthritis, Colitis, Ulcerative. Rheumatoid arthritis (RA) Gotenfia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX …
Ranluspec (ranibizumab)
Wet Macular Degeneration, Macular Edema, Diabetic Retinopathy, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Ranluspec 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 …
Aqneursa (L-acetylleucine)
Niemann-Pick Disease, Type C. Aqneursa is indicated for the treatment of neurological manifestations of Niemann-Pick type C (NPC) disease, in combination with miglustat, or as a monotherapy in patients where miglustat is not tolerated, in adults and children aged 6 years and older and …
Dawnzera (donidalorsen)
Angioedemas, Hereditary. Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Inluriyo (imlunestrant tosilate)
Breast Neoplasms. Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior …
Ondibta (insulin glargine)
Diabetes Mellitus. Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
VacPertagen (recombinant pertussis toxin;filamentous haemagglutinin)
Whooping Cough, Infections. VacPertagen is indicated for: - booster immunisation against pertussis of individuals 12 years of age and older,- passive protection against pertussis in early infancy following maternal immunisation during pregnancy.
Waskyra (genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human Wiskott-Aldrich Syndrome (WAS) gene)
Wiskott-Aldrich Syndrome. Waskyra is indicated for the treatment of patients aged 6 months and older with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom haematopoietic stem cell (HSC) transplantation is appropriate and no suitable human leukocyte antigen …
Austedo (deutetrabenazine)
Tardive Dyskinesia. Treatment of moderate to severe tardive dyskinesia in adults.
GalenVita (germanium (68Ge) chloride;gallium (68Ga) chloride)
Radionuclide Imaging. This radionuclide generator is not intended for direct use in patients. The sterile eluate (gallium (68Ga) chloride solution) from the radionuclide generator GalenVita is indicated for in vitro radiolabelling of various kits for radiopharmaceutical …
Osqay (denosumab)
Bone Resorption. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation …
Teduglutide Viatris (teduglutide)
Short Bowel Syndrome. Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.
Teizeild (teplizumab)
Diabetes Mellitus, Type 1. Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.