EMA approvals 2025
Human medicines granted an EU marketing authorisation through EMA in 2025 (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.
109 authorisations · 16 Orphan · 5 PRIME · 9 Conditional · 45 Biosimilar · 10 Generic or hybrid · EMA data as of Oct 14, 2026.
Wayrilz (rilzabrutinib)
Purpura, Thrombocytopenic, Idiopathic. Wayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)
Imaavy (nipocalimab)
Myasthenia Gravis. Imaavy is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti‑acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase …
Kyinsu (insulin icodec;semaglutide)
Diabetes Mellitus, Type 2. Kyinsu is indicated for the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists as an adjunct to diet and exercise in addition to oral antidiabetic medicinal …
Svariya (previously Rivaroxaban Koanaa) (rivaroxaban)
Venous Thromboembolism, Pulmonary Embolism, Venous Thrombosis, Stroke, Embolism. Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. …
Brinsupri (Brensocatib monohydrate)
Bronchiectasis, Lung Diseases. Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
Acvybra (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Acvybra significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation …
Degevma (denosumab)
Giant Cell Tumor of Bone, Neoplasms, Bone Tissue. 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 …
Gobivaz (golimumab)
Arthritis, Rheumatoid, Arthritis, Juvenile, Arthritis, Psoriatic, Axial Spondyloarthritis, Colitis, Ulcerative, Non-Radiographic Axial Spondyloarthritis. Rheumatoid arthritis (RA) Gobivaz, 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 …
Kefdensis (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation …
Lynkuet (elinzanetant)
Hot Flashes, Menopause, Breast Neoplasms. Treatment of moderate to severe vasomotor symptoms (VMS).
Ponlimsi (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Ponlimsi significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation …
Usgena (ustekinumab)
Crohn Disease, Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative. Crohn’s Disease Usgena 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. …
Vysribli (previously Denosumab Intas) (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. 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. …
Xbonzy (denosumab)
Giant Cell Tumor of Bone, Neoplasms, Bone Tissue. 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 …
Zvogra (denosumab)
Giant Cell Tumor of Bone, Neoplasms, Bone Tissue. Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). …
Winlevi (clascoterone)
Acne Vulgaris. Adults Winlevi is indicated for the treatment of acne vulgaris. Adolescents (from 12 to < 18 years of age) Winlevi is indicated for the treatment of facial acne vulgaris.
Kisunla (donanemab)
Alzheimer Disease, Cognitive Dysfunction. Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or …
Macitentan Accord (macitentan)
Hypertension, Pulmonary. AdultsMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1). …
Macitentan AccordPharma (macitentan)
Hypertension, Pulmonary. AdultsMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (seesection 5.1)Paediatric populationMacitentan …
Bildyos (denosumab)
Bone Resorption, Osteoporosis, Postmenopausal, Osteoporosis. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Inpostmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hipfractures. …
Bilprevda (denosumab)
Giant Cell Tumor of Bone, Neoplasms, Bone Tissue. 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 …
Ekterly (sebetralstat)
Angioedemas, Hereditary. Ekterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Romvimza (vimseltinib dihydrate)
Giant Cell Tumor of Tendon Sheath. Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable …
Tryngolza (olezarsen sodium)
Hyperlipoproteinemia Type I. Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
Usrenty (ustekinumab)
Crohn Disease. Plaque psoriasis Usrenty 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 …
Voranigo (vorasidenib)
Oligodendroglioma, Astrocytoma. Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who …
Eyluxvi (aflibercept)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion. Eyluxvi is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),- …
Yeytuo (lenacapavir sodium)
HIV Infections, HIV-1. Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV 1 acquisition risk, weighing at least 35 kg for: oral …
Zemcelpro (allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel)
Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation. Treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available
Nintedanib Viatris (nintedanib)
Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial, Pulmonary Fibrosis. Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. …
Imreplys (sargramostim)
Acute Radiation Syndrome. Imreplys is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS). …
Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris (emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide fumarate)
HIV Infections. Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated …
Afiveg (aflibercept)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Afiveg is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual …
Mynzepli (aflibercept)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Mynzepli is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),- visual impairment due to diabetic …
Rezdiffra (resmetirom)
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Vivlipeg (pegfilgrastim)
Neutropenia, Febrile Neutropenia, Chemotherapy-Induced Febrile Neutropenia, Cancer. 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).
Eiyzey (aflibercept)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Eiyzey is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),- …
Ogsiveo (nirogacestat hydrobromide)
Desmoid Tumors. Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.
Usymro (ustekinumab)
Crohn Disease, Psoriasis, Arthritis, Psoriatic. Plaque psoriasis Usymro 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 …
Vgenfli (aflibercept)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Vgenfli is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),- visual impairment due to diabetic …
Maapliv (glycine,L-alanine,L-arginine,L-aspartic acid,L-cysteine hydrochloride monohydrate,L-histidine,L-methionine,L-phenylalanine,L-proline,L-serine,L-threonine,L-tryptophan,L-tyrosine,L-glutamic acid,L-lysine monohydrate,taurine)
Maple Syrup Urine Disease. Maapliv is indicated for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids free (BCAA- free) formulation.
Riulvy (tegomil fumarate)
Multiple Sclerosis, Relapsing-Remitting. Riulvy is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Blenrep (belantamab mafodotin)
Multiple Myeloma. Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone in …
Conexxence (denosumab)
Osteoporosis, Osteoporosis, Postmenopausal, 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. …
Emtricitabine / Tenofovir alafenamide Viatris (emtricitabine;tenofovir alafenamide fumarate)
HIV Infections. Emtricitabine/Tenofovir alafenamide Viatris is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 …
Itovebi (inavolisib)
Breast Neoplasms. Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 …
Attrogy (diflunisal)
Amyloid Neuropathies, Familial. Attrogy is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.
Aucatzyl (obecabtagene autoleucel)
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma. Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).
Bomyntra (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. …
Ezmekly (mirdametinib)
Neurofibromatosis 1, Neurofibroma, Plexiform. Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.
Rolcya (denosumab)
Osteoporosis, Osteoporosis, Postmenopausal, 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 …
Alyftrek (deutivacaftor;tezacaftor;vanzacaftor calcium dihydrate)
Cystic Fibrosis. Alyftrek tablets are indicated for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see sections 4.2 and 5.1).
Dazublys (trastuzumab)
Breast Neoplasms, Stomach Neoplasms. Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for …
Evfraxy (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Evfraxy significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation …
Oczyesa (octreotide hydrochloride)
Acromegaly. Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
Ziihera (zanidatamab)
Biliary Tract Neoplasms. Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient …
Denbrayce (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 (see section 5.1).Treatment of adults and skeletally mature adolescents with giant …
Enwylma (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 (see section 5.1).Treatment of adults and skeletally mature adolescents with giant …
Izamby (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. 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 …
Zadenvi (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. 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 …
Vevzuo (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 (see section 5.1).Treatment of adults and skeletally mature adolescents with giant …
Junod (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Junod significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in …
Yaxwer (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 …
Sephience (sepiapterin)
Phenylketonurias. Treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).
Tepezza (teprotumumab)
Graves Ophthalmopathy. Treatment of moderate to severe thyroid eye disease (TED).
Xoanacyl (ferric citrate coordination complex)
Iron Deficiencies, Renal Insufficiency, Chronic, Hyperphosphatemia. Xoanacyl is indicated for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
Duvyzat (givinostat hydrochloride monohydrate)
Muscular Dystrophy, Duchenne. Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
Qoyvolma (ustekinumab)
Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease. Adult Crohn’s Disease Qoyvolma 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 …
Ryjunea (atropine sulfate)
Myopia. Ryjunea is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.
Jubereq (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. …
Osvyrti (denosumab)
Bone Resorption, Osteoporosis, Osteoporosis, Postmenopausal. 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 …
Deqsiga (human normal immunoglobulin)
Immunologic Deficiency Syndromes, Purpura, Thrombocytopenic, Idiopathic, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. Replacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production. …
Trabectedin Accord (trabectedin)
Sarcoma, Ovarian Neoplasms. Trabectedin Accord is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. …
Lynozyfic (linvoseltamab)
Multiple Myeloma. Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated …
Vyjuvek (Beremagene geperpavec)
Epidermolysis Bullosa Dystrophica. Vyjuvek is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth
Leqembi (Lecanemab)
Cognitive Dysfunction, Alzheimer Disease. Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with …
Datroway (datopotamab deruxtecan)
Breast Neoplasms. Breast cancer Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the …
Dyrupeg (pegfilgrastim)
Neutropenia, Cancer. 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).
Eltrombopag Accord (eltrombopag olamine)
Purpura, Thrombocytopenic, Idiopathic. Eltrombopag Accord is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. …
Tivdak (tisotumab vedotin)
Uterine Cervical Neoplasms. Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).
Capvaxive (pneumococcal polysaccharide serotype 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B conjugated to CRM197 carrier protein)
Pneumococcal Infections. Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus …
Rytelo (imetelstat)
Anemia, Myelodysplastic Syndromes. Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
Wainzua (eplontersen sodium)
Amyloid Neuropathies, Familial. Treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.
Tuzulby (methylphenidate hydrochloride)
Attention Deficit Disorder with Hyperactivity. Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. …
Vimkunya (Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated)
Chikungunya virus. Vimkunya is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The use of this vaccine should be in accordance with official recommendations.
Paxneury (guanfacine hydrochloride)
Attention Deficit Disorder with Hyperactivity. Paxneury 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. …
Avtozma (tocilizumab)
Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Cytokine Release Syndrome, COVID-19 virus infection. Avtozma, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. …
Osenvelt (denosumab)
Giant Cell Tumor of Bone, Neoplasms, Bone Tissue. Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant …
Stoboclo (denosumab)
Osteoporosis, Postmenopausal, Osteoporosis, 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 …
Yesintek (ustekinumab)
Psoriasis, Arthritis, Psoriatic, Crohn Disease. Plaque psoriasis Yesintek 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 …
Emcitate (tiratricol)
Thyrotoxicosis, Heredodegenerative Disorders, Nervous System. Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
Eydenzelt (aflibercept)
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Retinal Vein Occlusion, Choroidal Neovascularization. Eydenzelt is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), …
Kostaive (COVID-19 sa-mRNA Vaccine)
COVID-19 virus infection. Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Nemluvio (nemolizumab)
Dermatitis, Atopic, Prurigo. Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. …
Obodence (denosumab)
Osteoporosis, Postmenopausal, Osteoporosis, 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. …
Welireg (belzutifan)
Carcinoma, Renal Cell, von Hippel-Lindau Disease. Renal cell carcinoma (RCC) Welireg is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two …
Xbryk (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 (see section 5.1). …
Zefylti (filgrastim)
Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer. Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic …
Andembry (garadacimab)
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.
Beyonttra (acoramidis hydrochloride)
Amyloid Neuropathies, Familial. For the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Korjuny (catumaxomab)
Ascites. Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.
Hetronifly (serplulimab)
Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Esophageal Squamous Cell Carcinoma. Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). …
Kavigale (sipavibart)
COVID-19 virus infection. Kavigale is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.Kavigale should …
Lazcluze (lazertinib mesilate monohydrate)
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.
Ahzantive (aflibercept)
Wet Macular Degeneration, Macular Edema, Retinal Vein Occlusion, Choroidal Neovascularization, Diabetes Complications. Ahzantive is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), • …
Augtyro (repotrectinib)
Carcinoma, Non-Small-Cell Lung, Cancer. Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). …
Baiama (aflibercept)
Wet Macular Degeneration, Macular Edema, Retinal Vein Occlusion, Choroidal Neovascularization, Diabetes Complications. Baiama is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual …
Gohibic (vilobelimab)
Respiratory Distress Syndrome, Adult, COVID-19 virus infection. Gohibic is indicated for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or …
Siiltibcy (Mycobacterium tuberculosis derived antigens (rdESAT‑6 and rCFP‑10))
Tuberculosis, Diagnosis. Diagnosis of infection with Mycobacterium tuberculosis.