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EU Drug Approvals

The European Medicines Agency approves new medicines for the whole EU at once. This is every medicine it has authorised since 1995, the ones it refused, and how long after the US each new drug arrived.

1,989 medicines the European Medicines Agency has authorised since 1995, 1,120 of them the first EU approval of their active substance, through Nov 12, 2026. Each new substance is matched to its first US approval, so you can see how far the EU runs behind or ahead.

  • Authorised in the last 12 months: 83
  • New substances, last 12 months: 43
  • Approved in the US first, last 5 years: 68%
  • Median lag when US first: 10 months
  • Refused or withdrawn, last 12 months: 13

New Active Substances per Year

First EU authorisations, 2005 to Nov 12, 2026.

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

  • Full year
  • 2026 to date

Months Behind the US

Median, for new substances the US approved first, by year of EU authorisation.

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

  • Full year
  • 2026 to date

New Substances by Drug Class

2022 to 2026.

  • Antineoplastic agents52
  • Immunosuppressants20
  • Other alimentary tract and metabolism products10
  • Other nervous system drugs7
  • Other hematological agents7
  • Antihemorrhagics6
  • Endocrine therapy5
  • Antivirals for systemic use4
  • Immunostimulants4
  • Pituitary and hypothalamic hormones and analogues4

Newest Authorisations

The last two years: new substances, new medicines of known substances, generics and biosimilars.
Nov 12, 2026Ruxolitinib ZentivaruxolitinibZentiva k.s.GenericMyelofibrosis (MF) Ruxolitinib Zentiva is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post…
Oct 22, 2026LynavoyLinerixibatGlaxoSmithKline Trading Services LimitedNew substance OrphanLynavoy is indicated for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).
Sep 25, 2026CavoleypegfilgrastimCuraTeQ Biologics s.r.oBiosimilarReduction 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…
Sep 21, 2026NezglyalleriglitazoneMinoryx Therapeutics S.L.New substance OrphanNezglyal 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. Gd negative) in brain Magnetic…
Sep 18, 2026Tafamidis AccordtafamidisAccord Healthcare S.L.U.GenericTafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRh-CM).
Sep 18, 2026Ruxolitinib Viatrisruxolitinib hemifumarateViatris LimitedGenericMyelofibrosis (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…
Sep 18, 2026SusvimoranibizumabRoche Registration GmbHNew medicineSusvimo 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…
Sep 18, 2026Icotydeicotrokinra hydrochlorideJanssen-Cilag InternationalNew substanceIcotyde 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
Sep 18, 2026ZokoveaensitrelvirShionogi B.V.New substancePost exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older
Aug 28, 2026Denosumab AscenddenosumabAscend GmbHBiosimilarPrevention 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…
Aug 20, 2026Hopledolevodopa;carbidopaZambon SpANew medicineHopledo 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)…
Aug 20, 2026DaybutrofinetideAcadia Pharmaceuticals B.V.New substance OrphanDaybu is indicated for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged 5 years and older.
Aug 20, 2026AujemfluInfluenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture)Seqirus Netherlands B.V.New medicineProphylaxis of influenza in adults 50 years of age and older. Aujemflu should be used in accordance with official recommendations.
Jul 24, 2026Colchicine Agepha PharmacolchicineAgepha Pharma s.r.o.New substanceColchicine AGEPHA Pharma is indicated for secondary prevention of atherothrombotic events in adult patients with coronary disease stable for at least 6 months.
Jul 20, 2026EtcamahcamizestrantAstraZeneca ABNew substanceEtcamah 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…
Jul 15, 2026JascaydnerandomilastBoehringer Ingelheim International GmbHNew substanceJascayd 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).
Jul 15, 2026Liraglutide STADAliraglutideSTADA Arzneimittel AGNew medicineTreatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise
Jul 15, 2026AblymicoliraglutideSTADA Arzneimittel AGNew medicineTreatment of weight management.
Jul 15, 2026VislyfaranibizumabLupin Europe GmbHBiosimilarVislyfa 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…
Jul 15, 2026VijoicealpelisibNovartis Europharm LimitedNew medicine Orphan ConditionalTreatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS)
Jul 15, 2026BoeytrenibotulinumtoxinEAbbVie LimitedNew substanceBoey 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…
Jun 30, 2026Itvismaonasemnogene abeparvovecNovartis Europharm LimitedNew medicineItvisma 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.
Jun 19, 2026Palbociclib ViatrispalbociclibViatris LimitedGenericPalbociclib 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. in combination with an…
Jun 19, 2026CenrifkitolebrutinibSanofi Winthrop IndustrieNew substanceCenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
Jun 19, 2026RexatiluxranibizumabIntas Third Party Sales 2005 S.L.BiosimilarRexatilux 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…
Jun 19, 2026RedemploplozasiranArrowhead Pharmaceuticals Ireland LimitedNew substance OrphanRedemplo 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).
May 29, 2026BopediatfurosemideProveca Pharma LimitedNew substanceBopediat 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.
May 29, 2026ImdylltratarlatamabAmgen Europe B.V.New substance OrphanImdylltra 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…
May 29, 2026ZepzelcalurbinectedinPharma Mar S.A.New substance OrphanZepzelca, 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…
May 28, 2026Adstiladrinnadofaragene firadenovecFerring Pharmaceuticals A/SNew substance ConditionalAdstiladrin 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…
May 21, 2026JoenjaleniolisibPharming Technologies B.V.New substance OrphanJoenja 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.
May 6, 2026Bysumloginsulin lisproSandoz GmbHBiosimilarFor 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.
Apr 27, 2026Dazpardainsulin aspartSandoz GmbHBiosimilarDazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Apr 27, 2026Onerjilevodopa;carbidopaTanabe Pharma GmbHNew medicineOnerji 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.
Apr 27, 2026XolremdimavorixaforNorgine B.V.New substance OrphanXolremdi 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…
Apr 27, 2026TuyorytocilizumabChemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)BiosimilarRheumatoid 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…
Apr 27, 2026ZandoriahteriparatideCinnaGen Co Unipessoal LDABiosimilarTeriparatide 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…
Apr 23, 2026PoherdypertuzumabOrganon N.V.BiosimilarEarly 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…
Apr 23, 2026PalsonifypaltusotineCrinetics Pharmaceuticals Europe GmbHNew substance OrphanPalsonify is indicated for the medical treatment of adult patients with acromegaly.
Apr 23, 2026FubelvetanerceptBiosimilar Collaborations Ireland LimitedBiosimilarRheumatoid 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,…
Apr 23, 2026RhapsidoremibrutinibNovartis Europharm LimitedNew substanceRhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
Apr 20, 2026mCombriaxinfluenza mRNA vaccine;COVID-19 mRNA vaccineModerna Biotech Spain, S.L.New substancemCombriax 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…
Apr 20, 2026OjemdatovorafenibIpsen PharmaNew substance Orphan ConditionalOjemda 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…
Apr 15, 2026EnflonsiaclesrovimabMerck Sharp Dohme LimitedNew substanceEnflonsia 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…
Mar 30, 2026Supemtektrivalent influenza vaccine (recombinant, prepared in cell culture)Sanofi Winthrop IndustrieNew substanceSupemtek 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.
Mar 26, 2026Kygevvidoxecitine;doxribtimineUCB PharmaNew substance Orphan PRIMEKygevvi 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.
Mar 26, 2026KayshildsemaglutideNovo Nordisk A/SNew medicine ConditionalKayshild 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…
Mar 26, 2026FylrevyestetrolGedeon Richter Plc.New substanceHormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal womenHormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women…
Mar 26, 2026Ilumiralutetium (177Lu) chlorideShine Europe B.V.New medicineIlumira 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…
Mar 24, 2026RezurockbelumosudilSanofi Winthrop IndustrieNew substance Orphan ConditionalRezurock 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…
Feb 16, 2026Anktivanogapendekin alfa inbakiceptImmunitybio Ireland LimitedNew substance ConditionalAnktiva 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…
Feb 12, 2026mNexspikeCOVID-19 mRNA vaccineModerna Biotech Spain, S.L.New medicinemNEXSPIKE 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.
Feb 12, 2026AumseqaAumolertinibSFL Pharmaceuticals Deutschland GmbHNew substanceAumseqa 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…
Feb 12, 2026MyqorzoaficamtenCytokinetics (Ireland) LimitedNew substanceMyqorzo is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
Feb 12, 2026ExdensurdepemokimabGlaxoSmithKline Trading Services LimitedNew substanceAsthma 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…
Feb 10, 2026GotenfiagolimumabStada Arzneimittel AGBiosimilarRheumatoid 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…
Feb 10, 2026RanluspecranibizumabLupin Europe GmbHBiosimilarRanluspec 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…
Jan 19, 2026AqneursaL-acetylleucineIntrabio Ireland LimitedNew substance OrphanAqneursa 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…
Jan 19, 2026DawnzeradonidalorsenOtsuka Pharmaceutical Netherlands B.V.New substanceDawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Jan 9, 2026Ondibtainsulin glargineSandoz GmbHBiosimilarTreatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Jan 9, 2026Waskyraetuvetidigene autotemcelFondazione Telethon ETSNew substance OrphanWaskyra 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…
Jan 9, 2026VacPertagenpertussis vaccine (recombinant, acellular, component, adsorbed)BioNet EuropeNew substanceVacPertagen 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.
Jan 9, 2026InluriyoimlunestrantEli Lilly Nederland B.V.New substanceInluriyo 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…
Jan 8, 2026Teduglutide ViatristeduglutideViatris LimitedGenericTeduglutide 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…
Jan 8, 2026TeizeildteplizumabSanofi Winthrop IndustrieNew substance PRIMETeizeild 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.
Jan 8, 2026OsqaydenosumabTheramex Ireland LimitedBiosimilarTreatment 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…
Jan 8, 2026AustedodeutetrabenazineTeva GmbHNew substanceTreatment of moderate to severe tardive dyskinesia in adults.
Jan 8, 2026GalenVitagermanium (68Ge) chloride;gallium (68Ga) chlorideCurium Romania S.R.L.New substanceThis 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…
Dec 22, 2025WayrilzrilzabrutinibSanofi B.V.New substance OrphanWayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)
Nov 28, 2025ImaavynipocalimabJanssen Cilag International NVNew substanceImaavy 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…
Nov 24, 2025Kyinsuinsulin icodec;semaglutideNovo Nordisk A/SNew substanceKyinsu 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…
Nov 21, 2025Svariya (previously Rivaroxaban Koanaa)rivaroxabanPGF Pharma International d.o.o.GenericPrevention 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…
Nov 18, 2025BrinsupriBrensocatibInsmed Netherlands B.V.New substance PRIMEBrinsupri 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.
Nov 17, 2025DegevmadenosumabTeva GmbHBiosimilarPrevention 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…
Nov 17, 2025GobivazgolimumabAdvanz Pharma LimitedBiosimilarRheumatoid 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…
Nov 17, 2025XbonzydenosumabReddy Holding GmbHBiosimilarPrevention 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…
Nov 17, 2025LynkuetelinzanetantBayer AGNew substanceTreatment of moderate to severe vasomotor symptoms (VMS).
Nov 17, 2025UsgenaustekinumabStada Arzneimittel AGBiosimilarCrohn’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…
Nov 17, 2025KefdensisdenosumabStada Arzneimittel AGBiosimilarTreatment 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…
Nov 17, 2025AcvybradenosumabReddy Holding GmbHBiosimilarTreatment 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…
Nov 17, 2025Vysribli (previously Denosumab Intas)VysribliIntas Third Party Sales 2005 S.L.BiosimilarTreatment 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…
Nov 17, 2025PonlimsidenosumabTeva GmbHBiosimilarTreatment 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…
Nov 17, 2025ZvogradenosumabStada Arzneimittel AGBiosimilarPrevention 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…
Oct 17, 2025WinleviclascoteroneCassiopea S.p.A.New substanceAdults 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.
Sep 24, 2025Macitentan AccordmacitentanAccord HealthcareGenericAdultsMacitentan 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). Paediatric…
Sep 24, 2025Macitentan AccordPharmamacitentanAccord HealthcareGenericAdultsMacitentan 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…
Sep 24, 2025KisunladonanemabEli Lilly Nederland B.V.New substanceDonanemab 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…
Sep 17, 2025BildyosdenosumabSciencepharma Sp. z o.oBiosimilarTreatment 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. Treatment of…
Sep 17, 2025TryngolzaolezarsenSwedish Orphan Biovitrum AB (publ)New substanceTryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
Sep 17, 2025BilprevdadenosumabSciencepharma Sp. z o.oBiosimilarPrevention 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…
Sep 17, 2025UsrentyustekinumabBiosimilar Collaborations Ireland LimitedBiosimilarPlaque 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…
Sep 17, 2025VoranigovorasidenibLes Laboratoires ServierNew substance OrphanVoranigo 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…
Sep 17, 2025EkterlysebetralstatKalvista Pharmaceuticals (Ireland) LimitedNew substance OrphanEkterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Sep 17, 2025RomvimzavimseltinibDeciphera Pharmaceuticals (Netherlands) B.V.New substance OrphanRomvimza 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…
Sep 15, 2025EyluxviafliberceptBiolitec pharma Limited Zweigniederlassung JenaBiosimilarEyluxvi 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…
Aug 25, 2025YeytuolenacapavirGilead Sciences Ireland Unlimited CompanyNew medicineYeytuo 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…
Aug 25, 2025Zemcelproallogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicelCordex Biologics International LimitedNew substance Orphan Conditional PRIMETreatment 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…
Aug 22, 2025Nintedanib ViatrisnintedanibViatris LimitedGenericNintedanib 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…
Aug 21, 2025ImreplyssargramostimPartner Therapeutics LimitedNew substanceImreplys 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). Imreplys should be used in…
Aug 19, 2025Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatrisemtricitabine;rilpivirine;tenofovir alafenamideViatris LimitedGenericEmtricitabine/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…
Aug 18, 2025RezdiffraresmetiromMadrigal Pharmaceuticals EU LimitedNew substance ConditionalRezdiffra 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…
Aug 18, 2025MynzepliafliberceptAdvanz Pharma LimitedBiosimilarMynzepli 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),-…
Aug 18, 2025AfivegafliberceptSTADA Arzneimittel AGBiosimilarAfiveg 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…
Aug 18, 2025VivlipegpegfilgrastimBiosimilar Collaborations Ireland LimitedBiosimilarReduction 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…
Aug 14, 2025OgsiveonirogacestatMerck Europe B.V.New substance OrphanOgsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.
Aug 14, 2025VgenfliafliberceptZaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.BiosimilarVgenfli 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),-…
Aug 14, 2025EiyzeyafliberceptZaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.BiosimilarEiyzey 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…
Aug 14, 2025UsymroustekinumabGedeon Richter Plc.BiosimilarPlaque 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…
Jul 28, 2025Maaplivamino acidsRecordati Rare DiseasesNew substance OrphanMaapliv 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…
Jul 28, 2025Riulvytegomil fumarateNeuraxpharm Pharmaceuticals S.L.GenericRiulvy is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Jul 23, 2025Blenrepbelantamab mafodotinGlaxoSmithKline Trading Services LimitedNew medicineBlenrep 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…
Jul 18, 2025ConexxencedenosumabFresenius Kabi Deutschland GmbHBiosimilarTreatment 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…
Jul 18, 2025ItovebiinavolisibRoche Registration GmbHNew substanceItovebi, 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…
Jul 18, 2025Emtricitabine / Tenofovir alafenamide Viatrisemtricitabine;tenofovir alafenamideViatris LimitedGenericEmtricitabine/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…
Jul 17, 2025EzmeklymirdametinibMerck Europe B.V.New substance Orphan ConditionalEzmekly 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.
Jul 17, 2025BomyntradenosumabFresenius Kabi Deutschland GmbHBiosimilarPrevention 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…
Jul 17, 2025AttrogydiflunisalPurpose Pharma International ABNew substanceAttrogy is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.
Jul 17, 2025RolcyadenosumabSandoz GmbHBiosimilarTreatment 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…
Jul 17, 2025Aucatzylobecabtagene autoleucelAutolus GmbHNew substance Conditional PRIMEAucatzyl 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).
Jun 30, 2025Alyftrekdeutivacaftor / tezacaftor / vanzacaftorVertex Pharmaceuticals (Ireland) LimitedNew substance OrphanAlyftrek 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…
Jun 30, 2025DazublystrastuzumabCuraTeQ Biologics (Malta) LimitedBiosimilarBreast 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…
Jun 30, 2025EvfraxydenosumabBiosimilar Collaborations Ireland LimitedBiosimilarTreatment 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…
Jun 30, 2025OczyesaoctreotideCamurus ABNew medicineOczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
Jun 27, 2025ZiiherazanidatamabJazz Pharmaceuticals Ireland LimitedNew substance Orphan ConditionalZiihera 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…
Jun 26, 2025DenbraycedenosumabMabxience Research SLBiosimilarPrevention 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…
Jun 26, 2025EnwylmadenosumabZentiva k.s.BiosimilarPrevention 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…
Jun 26, 2025ZadenvidenosumabZentiva k.s.BiosimilarTreatment 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…
Jun 26, 2025IzambydenosumabMabxience Research SLBiosimilarTreatment 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…
Jun 25, 2025VevzuodenosumabBiosimilar Collaborations Ireland LimitedBiosimilarPrevention 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…
Jun 23, 2025YaxwerdenosumabGedeon Richter Plc.BiosimilarPrevention 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…
Jun 23, 2025JunoddenosumabGedeon Richter Plc.BiosimilarTreatment 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…
Jun 19, 2025SephiencesepiapterinPTC Therapeutics International LimitedNew substance OrphanTreatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).
Jun 19, 2025TepezzateprotumumabAmgen Europe B.V.New substanceTreatment of moderate to severe thyroid eye disease (TED).
Jun 11, 2025Xoanacylferric citrate coordination complexAveroaNew medicineXoanacyl is indicated for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
Jun 6, 2025DuvyzatgivinostatItalfarmaco S.p.A.New substance Orphan ConditionalDuvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
Jun 2, 2025QoyvolmaustekinumabCelltrion Healthcare Hungary Kft.BiosimilarAdult 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…
Jun 2, 2025Ryjuneaatropine sulfateSanten OyNew substanceRyjunea 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…
May 26, 2025JubereqdenosumabAccord Healthcare S.L.U.BiosimilarPrevention 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…
May 26, 2025OsvyrtidenosumabAccord Healthcare S.L.U.BiosimilarTreatment 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…
May 2, 2025Deqsigahuman normal immunoglobulinTakeda Manufacturing Austria AGNew medicineReplacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production. - Secondary immunodeficiencies (SID) in patients who suffer from…
Apr 25, 2025Trabectedin AccordtrabectedinAccord Healthcare S.L.U.GenericTrabectedin 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. Efficacy data are based…
Apr 23, 2025Vyjuvekberemagene geperpavecKrystal Biotech Netherlands B.V.New substance Orphan PRIMEVyjuvek 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
Apr 23, 2025LynozyficlinvoseltamabRegeneron Ireland Designated Activity Company (DAC)New substance ConditionalMonotherapy 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…
Apr 15, 2025LeqembilecanemabEisai GmbHNew substanceLeqembi 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…
Apr 4, 2025Datrowaydatopotamab deruxtecanDaiichi Sankyo Europe GmbHNew substanceBreast 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…
Mar 28, 2025Eltrombopag AccordeltrombopagAccord Healthcare S.L.U.GenericEltrombopag Accord is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is…
Mar 28, 2025DyrupegpegfilgrastimCuraTeQ Biologics (Malta) LimitedBiosimilarReduction 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…
Mar 28, 2025Tivdaktisotumab vedotinGenmab A/SNew substanceTivdak 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).
Mar 24, 2025Capvaxivepneumococcal polysaccharide conjugate vaccine (21-valent)Merck Sharp & Dohme B.V.New medicineCapvaxive 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…
Mar 7, 2025RyteloimetelstatGeron Netherlands B.V.New substance OrphanTreatment 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…
Mar 6, 2025WainzuaeplontersenAstraZeneca ABNew substanceTreatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.
Feb 28, 2025Tuzulbymethylphenidate hydrochlorideNeuraxpharm Pharmaceuticals S.L.New substanceTuzulby 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.…
Feb 28, 2025VimkunyaChikungunya vaccine (recombinant, adsorbed)Bavarian Nordic A/SNew medicine PRIMEVimkunya 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…
Feb 26, 2025PaxneuryguanfacineNeuraxpharm Pharmaceuticals S.L.GenericPaxneury 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…
Feb 14, 2025OsenveltdenosumabCelltrion Healthcare Hungary Kft.BiosimilarPrevention 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…
Feb 14, 2025AvtozmatocilizumabCelltrion Healthcare Hungary Kft.BiosimilarAvtozma, 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. the treatment of moderate to severe…
Feb 14, 2025YesintekustekinumabBiosimilar Collaborations Ireland LimitedBiosimilarPlaque 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…
Feb 14, 2025StoboclodenosumabCelltrion Healthcare Hungary Kft.BiosimilarTreatment 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…
Feb 12, 2025EydenzeltafliberceptCelltrion Healthcare Hungary Kft.BiosimilarEydenzelt 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…
Feb 12, 2025KostaivezapomeranArcturus Therapeutics Europe B.V.New substanceKostaive 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.
Feb 12, 2025WeliregbelzutifanMerck Sharp & Dohme B.V.New substance ConditionalRenal 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…
Feb 12, 2025NemluvionemolizumabGalderma InternationalNew substanceAtopic 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. Prurigo nodularis (PN) Nemluvio is…
Feb 12, 2025XbrykdenosumabSamsung Bioepis NL B.V.BiosimilarPrevention 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…
Feb 12, 2025ObodencedenosumabSamsung Bioepis NL B.V.BiosimilarTreatment 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…
Feb 12, 2025ZefyltifilgrastimCuraTeQ Biologics (Malta) LimitedBiosimilarZefylti 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…
Feb 12, 2025EmcitatetiratricolRare Thyroid Therapeutics International ABNew substance OrphanEmcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
Feb 10, 2025AndembrygaradacimabCSL Behring GmbHNew substanceAndembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
Feb 10, 2025BeyonttraacoramidisBayer AGNew substanceFor the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Feb 10, 2025KorjunycatumaxomabAtnahs Pharma Netherlands B.V.New medicineKorjuny 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.
Feb 3, 2025HetroniflyserplulimabAccord Healthcare S.L.U.New substanceSmall 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). Non-small cell…
Jan 20, 2025LazcluzelazertinibJanssen Cilag International NVNew substanceLazcluze 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.
Jan 20, 2025KavigalesipavibartAstraZeneca ABNew substanceKavigale 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…
Jan 13, 2025AhzantiveafliberceptFormycon AGBiosimilarAhzantive 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…
Jan 13, 2025BaiamaafliberceptFormycon AGBiosimilarBaiama 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…
Jan 13, 2025GohibicvilobelimabInflaRx GmbHNew substanceGohibic 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…
Jan 13, 2025SiiltibcyMycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10)Serum Life Science Europe GmbHNew substanceDiagnosis of infection with Mycobacterium tuberculosis.
Jan 13, 2025AugtyrorepotrectinibBristol-Myers Squibb Pharma EEIGNew substance ConditionalAugtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric…
Dec 19, 2024Buprenorphine NeuraxpharmbuprenorphineNeuraxpharm Pharmaceuticals S.L.New medicineSubstitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years…
Dec 13, 2024AlhemoconcizumabNovo Nordisk A/SNew substanceAlhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with: • haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors.• severe haemophilia A (congenital factor VIII…
Dec 12, 2024ImuldosaustekinumabAccord Healthcare S.L.U.BiosimilarAdult Crohn’s Disease Imuldosa 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…
Dec 12, 2024Eltrombopag ViatriseltrombopagViatris LimitedGenericEltrombopag Viatris is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Viatris is…
Dec 12, 2024AbsimkyustekinumabAccord Healthcare S.L.U.BiosimilarPlaque psoriasis ABSIMKY 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…
Nov 22, 2024Theralugandlutetium (177Lu) chlorideEckert & Ziegler Radiopharma GmbHNew medicineTheralugand 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…
Nov 18, 2024HympavzimarstacimabPfizer Europe MA EEIGNew substanceHympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: Haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors…
Nov 15, 2024Flucelvaxinfluenza vaccine (surface antigen, inactivated, prepared in cell cultures)Seqirus Netherlands B.V.New medicineProphylaxis of influenza in adults and children from 6 months of age. Flucelvax should be used in accordance with official recommendations.
Nov 15, 2024Fluadinfluenza vaccine (surface antigen, inactivated, adjuvanted)Seqirus Netherlands B.V.New medicineProphylaxis of influenza in adults 50 years of age and older. Fluad should be used in accordance with official recommendations.
Nov 14, 2024Pomalidomide TevapomalidomideTeva GmbHGenericPomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.…
Nov 14, 2024Elaheremirvetuximab soravtansineAbbVie Deutschland GmbH & Co. KGNew substance OrphanElahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer…
Nov 14, 2024Penbrayameningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)Pfizer Europe MA EEIGNew substancePenbraya is indicated for active immunisation of individuals 10 years of age and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y. The use of this vaccine should be in…
Nov 13, 2024AfqlirafliberceptSandoz GmbHBiosimilarAfqlir 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) •…
Nov 13, 2024OpuvizafliberceptSamsung Bioepis NL B.V.BiosimilarOpuviz 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)…

Refused and Withdrawn Applications

Since 2023. A withdrawn application usually means the committee was heading for a negative opinion.
Oct 30, 2026QezzaqarcatequentinibCATS Consultants GmbHApplication withdrawnSarcoma
Oct 30, 2026AmlypaveanselamimabAlexion EuropeApplication withdrawnImmunoglobulin Light-chain Amyloidosis
Sep 14, 2026TacquellAutologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expandedNetherlands Cancer InstituteRefusedMelanoma
Aug 21, 2026Kinselbyresminostat4Sc AGRefusedMycosis Fungoides
Aug 13, 2026IsembyldapitegromabScholar Rock Netherlands B.V.Application withdrawnMuscular Atrophy, Spinal
Aug 3, 2026Deqtynetcopper (64Cu) oxodotreotideCIS bio internationalRefusedRadionuclide Imaging
Jul 22, 2026ZinmyleotrilaciclibPharmacosmos A/SApplication withdrawnSmall Cell Lung Carcinoma
Jul 13, 2026Azacitidine AdienneazacitidineAdienne S.r.l. S.U.Application withdrawnMyelodysplastic Syndromes
Jun 12, 2026Iloperidone Vanda PharmaceuticalsiloperidoneVanda Pharmaceuticals Netherlands B.V.RefusedSchizophrenia
May 21, 2026OrblidbevacizumabLaboratoires DelbertApplication withdrawnTelangiectasia, Hereditary Hemorrhagic
May 8, 2026VeblocemainfliximabCelltrion Healthcare Hungary Kft.Application withdrawnArthritis, Rheumatoid
Mar 25, 2026Blarcamesine AnavexblarcamesineNot listedApplication withdrawnPsychoanaleptics
Nov 21, 2025Atropine sulfate FGKatropineFGK Representative Service GmbHRefusedMyopia
Nov 11, 2025Jelrixautologous cartilage-derived articular chondrocytes, in-vitro expandedTETEC Tissue Engineering Technologies AGApplication withdrawnKnee Injuries
Nov 7, 2025NurzigmapridopidinePrilenia Therapeutics B.V.Application withdrawnHuntington Disease
Oct 30, 2025OhtuvayreensifentrineVerona Pharma Ireland LimitedApplication withdrawnPulmonary Disease, Chronic Obstructive
Oct 17, 2025Insulin Aspart Injectioninsulin aspartMasuu Pharma Europe LimitedApplication withdrawnDiabetes Mellitus
Sep 24, 2025Elevidysdelandistrogene moxeparvovecRoche Registration GmbHRefusedMuscular Dystrophy, Duchenne
Sep 18, 2025Hydrocortisone AguettanthydrocortisoneLaboratoire AguettantApplication withdrawnBronchopulmonary Dysplasia
Sep 12, 2025OmforromidazolamRegulatory Pharma Net S.r.l.Application withdrawnConscious Sedation
Sep 12, 2025TuzodimidazolamRegulatory Pharma Net S.r.l.Application withdrawnSeizures
Aug 22, 2025FanskyaMozafancogene autotemcelRocket Pharmaceuticals B.V.Application withdrawnFanconi Anemia
Jul 22, 2025AmtagvilifileucelIovance Biotherapeutics B.V.Application withdrawnMelanoma
Jul 18, 2025IfinwileflornithineNorgine B.V.Application withdrawnNeuroblastoma
Jun 24, 2025Nidlegybifikafusp alfa;onfekafusp alfaPhilogen S.p.A.Application withdrawnMelanoma
May 6, 2025Teriparatide AscendteriparatideAscend GmbHApplication withdrawnOsteoporosis
May 2, 2025KizfizotemozolomideORPHELIA PharmaRefusedNeuroblastoma
Mar 24, 2025DazlumatroriluzoleBiohaven Bioscience Ireland LimitedApplication withdrawnSpinocerebellar Ataxias
Mar 18, 2025Insulin Human Rechoninsulin humanRechon Life Science ABApplication withdrawnDiabetes Mellitus
Mar 12, 2025SkojoyafliberceptAmgen Technology (Ireland) UCApplication withdrawnWet Macular Degeneration
Feb 26, 2025Cinainudry aqueous extract of paullinia cupana seed;dry hydroethanolic extract of theobroma cacao seed;liquid ethanolic extract 30 per cent (W/W) of Allium cepa fresh bulb and Citrus limon fresh fruitLegacy Healthcare (France) S.A.S.Application withdrawnAlopecia Areata
Feb 20, 2025Pelgraz PaediatricpegfilgrastimAccord Healthcare S.L.U.Application withdrawnNeutropenia
Feb 12, 2025Rilonacept FGK Representative Service GmbHrilonaceptRilonacept FGK Representative Service GmbHApplication withdrawnPericarditis
Dec 20, 2024Datopotamab deruxtecan Daiichi Sankyodatopotamab deruxtecanDaiichi Sankyo Europe GmbHApplication withdrawnCarcinoma, Non-Small-Cell Lung
Dec 19, 2024Masitinib AB SciencemasitinibAB ScienceRefusedAmyotrophic Lateral Sclerosis
Dec 16, 2024SyfovrepegcetacoplanApellis Europe B.V.RefusedMacular Degeneration
Dec 10, 2024NugalviqgovorestatAdvanz Pharma LimitedApplication withdrawnGalactosemias
Oct 24, 2024Izelvayavacincaptad pegolAstellas Pharma Europe B.V.Application withdrawnMacular Degeneration
Sep 19, 2024EpixramlevetiracetamNeuraxpharm Pharmaceuticals S.L.Application withdrawnEpilepsy
Sep 17, 2024Apremilast ViatrisapremilastViatris LimitedApplication withdrawnArthritis, Psoriatic
Sep 13, 2024DurystabimatoprostAbbVie Deutschland GmbH & Co. KGApplication withdrawnGlaucoma, Open-Angle
Jul 22, 2024NezglyalleriglitazoneMinoryx Therapeutics S.L.RefusedAdrenoleukodystrophy
Jun 13, 2024Dabigatran etexilate Tevadabigatran etexilateTeva GmbHApplication withdrawnVenous Thromboembolism
May 7, 2024Kinhartoomecamtiv mecarbilCytokinetics (Ireland) LimitedRefusedHeart Failure, Systolic
Apr 15, 2024GeGantgermanium (68Ge) chloride;gallium (68Ga) chlorideITM Medical Isotopes GmbHApplication withdrawnRadionuclide Imaging
Mar 22, 2024UpsteldaustekinumabAmgen Technology (Ireland) UCApplication withdrawnPsoriasis
Jan 5, 2024Albriozasodium phenylbutyrate;ursodoxicoltaurineAmylyx Pharmaceuticals EMEA B.V.RefusedAmyotrophic Lateral Sclerosis
Oct 30, 2023VijoicealpelisibNovartis Europharm LimitedApplication withdrawnGenetic Diseases, Inborn
Sep 28, 2023Sugammadex Loriensugammadex sodiumLABORATORIOS LORIEN, S.LApplication withdrawnAll other therapeutic products
Sep 12, 2023Jivadcotrastuzumab duocarmazinemedac Gesellschaft für klinische Spezialpräparate mbHApplication withdrawnAntineoplastic agents
Sep 1, 2023SkycovionGBP510SK Chemicals GmbHApplication withdrawnVaccines
Aug 24, 2023VivjoaoteseconazoleGedeon Richter Plc.Application withdrawnCandidiasis
Jul 19, 2023LutholazpegfilgrastimYES Pharmaceutical Development Services GmbHApplication withdrawnImmunostimulants
Jul 17, 2023SohonospalovaroteneIpsen PharmaRefusedMyositis Ossificans
Jul 14, 2023GefzurisgefapixantMerck Sharp & Dohme B.V.Application withdrawnCough
Jul 12, 2023JesduvroqdaprodustatGlaxoSmithKline Trading Services LimitedApplication withdrawnRenal Insufficiency, Chronic
Jun 21, 2023LagevriomolnupiravirMerck Sharp & Dohme B.V.Application withdrawnCOVID-19 virus infection
Jun 8, 2023DyrupegpegfilgrastimCuraTeQ Biologics s.r.oApplication withdrawnpegfilgrastim
Jun 8, 2023ZefyltifilgrastimCuraTeQ Biologics s.r.oApplication withdrawnfilgrastim
May 2, 2023SusvimoranibizumabRoche Registration GmbHApplication withdrawnWet Macular Degeneration
May 2, 2023AsimtufiiaripiprazoleOtsuka Pharmaceutical Netherlands B.V.Application withdrawnSchizophrenia
Apr 20, 2023Lumevoqlenadogene nolparvovecGenSight Biologics S.A.Application withdrawnOptic Atrophy, Hereditary, Leber
Apr 12, 2023Omblastysiodine (131I) omburtamabY-Mabs Therapeutics A/SRefusedNeuroblastoma
Mar 27, 2023TidhescoivosidenibLes Laboratoires ServierApplication withdrawnLeukemia, Myeloid, Acute
Mar 9, 2023FerahemeferumoxytolCovis Pharma Europe B.V.Application withdrawnAnemia, Iron-Deficiency
Feb 22, 2023Raltegravir Viatrisraltegravir potassiumViatris LimitedApplication withdrawnHIV Infections

Every New Active Substance

With the first US approval of the same ingredient. Sort by the gap to find the longest waits.
Oct 22, 2026LynavoyLinerixibatGlaxoSmithKline Trading Services LimitedBile and liver therapyMar 17, 20267 mo later
Sep 21, 2026NezglyalleriglitazoneMinoryx Therapeutics S.L.Other alimentary tract and metabolism productsNo US match—
Sep 18, 2026Icotydeicotrokinra hydrochlorideJanssen-Cilag InternationalImmunosuppressantsMar 17, 20266 mo later
Sep 18, 2026ZokoveaensitrelvirShionogi B.V.Antivirals for systemic useMay 29, 20264 mo later
Aug 20, 2026DaybutrofinetideAcadia Pharmaceuticals B.V.Other nervous system drugsMar 10, 202341 mo later
Jul 24, 2026Colchicine Agepha PharmacolchicineAgepha Pharma s.r.o.Antigout preparationsJul 29, 2009204 mo later
Jul 20, 2026EtcamahcamizestrantAstraZeneca ABEndocrine therapySep 4, 20262 mo earlier
Jul 15, 2026JascaydnerandomilastBoehringer Ingelheim International GmbHImmunosuppressantsOct 7, 20259 mo later
Jul 15, 2026BoeytrenibotulinumtoxinEAbbVie LimitedMUSCLE RELAXANTS;Other muscle relaxants, peripherally acting agentsNo US match—
Jun 19, 2026CenrifkitolebrutinibSanofi Winthrop IndustrieSelective immunosuppressantsNo US match—
Jun 19, 2026RedemploplozasiranArrowhead Pharmaceuticals Ireland LimitedLipid modifying agentsNov 18, 20257 mo later
May 29, 2026BopediatfurosemideProveca Pharma LimitedSulfonamides, plain;DiureticsOct 7, 202244 mo later
May 29, 2026ImdylltratarlatamabAmgen Europe B.V.Antineoplastic agentsMay 16, 202424 mo later
May 29, 2026ZepzelcalurbinectedinPharma Mar S.A.Antineoplastic agentsJun 15, 202071 mo later
May 28, 2026Adstiladrinnadofaragene firadenovecFerring Pharmaceuticals A/SAntineoplastic agentsDec 16, 202241 mo later
May 21, 2026JoenjaleniolisibPharming Technologies B.V.Antineoplastic agentsMar 24, 202338 mo later
Apr 27, 2026XolremdimavorixaforNorgine B.V.ImmunostimulantsApr 26, 202424 mo later
Apr 23, 2026PalsonifypaltusotineCrinetics Pharmaceuticals Europe GmbHPituitary and hypothalamic hormones and analoguesSep 25, 20257 mo later
Apr 23, 2026RhapsidoremibrutinibNovartis Europharm LimitedImmunosuppressantsSep 30, 20257 mo later
Apr 20, 2026mCombriaxinfluenza mRNA vaccine;COVID-19 mRNA vaccineModerna Biotech Spain, S.L.VaccinesNo US match—
Apr 20, 2026OjemdatovorafenibIpsen PharmaAntineoplastic agentsApr 23, 202424 mo later
Apr 15, 2026EnflonsiaclesrovimabMerck Sharp Dohme LimitedImmune sera and immunoglobulinsJun 9, 202510 mo later
Mar 30, 2026Supemtektrivalent influenza vaccine (recombinant, prepared in cell culture)Sanofi Winthrop IndustrieVaccinesNo US match—
Mar 26, 2026Kygevvidoxecitine;doxribtimineUCB PharmaOther alimentary tract and metabolism productsNov 3, 20255 mo later
Mar 26, 2026FylrevyestetrolGedeon Richter Plc.Sex hormones and modulators of the genital systemNo US match—
Mar 24, 2026RezurockbelumosudilSanofi Winthrop IndustrieImmunosuppressantsJul 16, 202156 mo later
Feb 16, 2026Anktivanogapendekin alfa inbakiceptImmunitybio Ireland LimitedImmunostimulantsApr 22, 202422 mo later
Feb 12, 2026AumseqaAumolertinibSFL Pharmaceuticals Deutschland GmbHAntineoplastic agentsNo US match—
Feb 12, 2026MyqorzoaficamtenCytokinetics (Ireland) Limited—Dec 19, 20252 mo later
Feb 12, 2026ExdensurdepemokimabGlaxoSmithKline Trading Services LimitedDrugs for obstructive airway diseasesDec 16, 20252 mo later
Jan 19, 2026AqneursaL-acetylleucineIntrabio Ireland LimitedOther nervous system drugsNo US match—
Jan 19, 2026DawnzeradonidalorsenOtsuka Pharmaceutical Netherlands B.V.Other hematological agentsAug 21, 20255 mo later
Jan 9, 2026Waskyraetuvetidigene autotemcelFondazione Telethon ETSOther hematological agentsDec 9, 20251 mo later
Jan 9, 2026VacPertagenpertussis vaccine (recombinant, acellular, component, adsorbed)BioNet EuropeVaccinesNo US match—
Jan 9, 2026InluriyoimlunestrantEli Lilly Nederland B.V.Endocrine therapySep 25, 20253 mo later
Jan 8, 2026TeizeildteplizumabSanofi Winthrop IndustrieDrugs used in diabetesNov 17, 202238 mo later
Jan 8, 2026AustedodeutetrabenazineTeva GmbHOther nervous system drugsApr 3, 2017105 mo later
Jan 8, 2026GalenVitagermanium (68Ge) chloride;gallium (68Ga) chlorideCurium Romania S.R.L.Diagnostic radiopharmaceuticalsNo US match—
Dec 22, 2025WayrilzrilzabrutinibSanofi B.V.Not assigned yetAug 29, 20254 mo later
Nov 28, 2025ImaavynipocalimabJanssen Cilag International NVImmunosuppressantsApr 29, 20257 mo later
Nov 24, 2025Kyinsuinsulin icodec;semaglutideNovo Nordisk A/SInsulins and analogues for injection, long-actingNo US match—
Nov 18, 2025BrinsupriBrensocatibInsmed Netherlands B.V.—Aug 12, 20253 mo later
Nov 17, 2025LynkuetelinzanetantBayer AGOther gynecologicalsOct 24, 20251 mo later
Oct 17, 2025WinleviclascoteroneCassiopea S.p.A.Other anti-acne preparations for topical useAug 26, 202062 mo later
Sep 24, 2025KisunladonanemabEli Lilly Nederland B.V.Anti-dementia drugs;Other anti-dementia drugsJul 2, 202415 mo later
Sep 17, 2025TryngolzaolezarsenSwedish Orphan Biovitrum AB (publ)Lipid modifying agentsDec 19, 20249 mo later
Sep 17, 2025VoranigovorasidenibLes Laboratoires ServierAntineoplastic agentsAug 6, 202413 mo later
Sep 17, 2025EkterlysebetralstatKalvista Pharmaceuticals (Ireland) LimitedOther hematological agentsJul 3, 20252 mo later
Sep 17, 2025RomvimzavimseltinibDeciphera Pharmaceuticals (Netherlands) B.V.Antineoplastic agentsFeb 14, 20257 mo later
Aug 25, 2025Zemcelproallogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicelCordex Biologics International LimitedOther blood productsNo US match—

Centrally authorised human medicines only; medicines authorised country by country are not in EMA's register. A new substance here is the first authorisation of an ingredient by a medicine that is not a generic or biosimilar; EMA does not flag new active substances in this file. The US match is by ingredient name, ignoring salts, from Drugs@FDA and the Purple Book. Reproduced under EMA's legal notice. Refreshed daily. European Medicines Agency (www.ema.europa.eu), medicines register

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.