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ib","region":"EU","status":"conditional","year":2025,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro","verifiedOn":"2026-09-30"},{"drugId":"pralsetinib","region":"EU","status":"withdrawn","year":2024,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/gavreto","verifiedOn":"2026-09-30"},{"drugId":"melflufen","region":"EU","status":"approved","year":2022,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pepaxti","verifiedOn":"2026-09-30"},{"drugId":"dacomitinib","region":"EU","status":"approved","year":2019,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vizimpro","verifiedOn":"2026-09-30"},{"drugId":"mechlorethamine","region":"EU","status":"approved","year":2017,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ledaga","verifiedOn":"2026-09-30"},{"drugId":"granisetron","region":"EU","status":"approved","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sancuso","verifiedOn":"2026-09-30"},{"drugId":"irinotecan","region":"EU","status":"approved","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal","verifiedOn":"2026-09-30"},{"drugId":"idelalisib","region":"EU","status":"approved","year":2014,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zydelig","verifiedOn":"2026-09-30"},{"drugId":"gefitinib","region":"EU","status":"approved","year":2009,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/iressa","verifiedOn":"2026-09-30"},{"drugId":"carmustine","region":"EU","status":"approved","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/carmustine-medac","verifiedOn":"2026-09-30"},{"drugId":"ziv-aflibercept","region":"EU","status":"approved","year":2013,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap","verifiedOn":"2026-09-30"},{"drugId":"tilmanocept-tc99m","region":"EU","status":"withdrawn","year":2024,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lymphoseek","verifiedOn":"2026-09-30"},{"drugId":"rasburicase","region":"EU","status":"approved","year":2001,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fasturtec","verifiedOn":"2026-09-30"},{"drugId":"toremifene","region":"EU","status":"approved","year":1996,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fareston","verifiedOn":"2026-09-30"},{"drugId":"clofarabine","region":"EU","status":"approved","year":2006,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/evoltra","verifiedOn":"2026-09-30"},{"drugId":"trifluridine-tipiracil","region":"EU","status":"approved","year":2016,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf","verifiedOn":"2026-09-30"},{"drugId":"epoetin-theta","region":"EU","status":"approved","year":2009,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/biopoin","verifiedOn":"2026-09-30"},{"drugId":"tivozanib","region":"EU","status":"approved","year":2017,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda","verifiedOn":"2026-09-30"},{"drugId":"histamine-dihydrochloride","region":"EU","status":"approved","year":2008,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene","verifiedOn":"2026-09-30"},{"drugId":"cytarabine","region":"EU","status":"withdrawn","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/depocyte","verifiedOn":"2026-09-30"},{"drugId":"padeliporfin","region":"EU","status":"approved","year":2017,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tookad","verifiedOn":"2026-09-30"},{"drugId":"moxetumomab-pasudotox","region":"EU","status":"withdrawn","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lumoxiti","verifiedOn":"2026-09-30"},{"drugId":"necitumumab","region":"EU","status":"withdrawn","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza","verifiedOn":"2026-09-30"},{"drugId":"alitretinoin","region":"EU","status":"withdrawn","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/panretin","verifiedOn":"2026-09-30"},{"drugId":"pexidartinib","region":"EU","status":"withdrawn","year":2020,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/turalio","verifiedOn":"2026-09-30"},{"drugId":"rolapitant","region":"EU","status":"withdrawn","year":2020,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/varuby","verifiedOn":"2026-09-30"},{"drugId":"ofatumumab","region":"EU","status":"withdrawn","year":2019,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra","verifiedOn":"2026-09-30"},{"drugId":"sipuleucel-t","region":"EU","status":"withdrawn","year":2015,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/provenge","verifiedOn":"2026-09-30"},{"drugId":"romidepsin","region":"EU","status":"withdrawn","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/istodax","verifiedOn":"2026-09-30"},{"drugId":"alemtuzumab","region":"EU","status":"withdrawn","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mabcampath","verifiedOn":"2026-09-30"},{"drugId":"pralatrexate","region":"EU","status":"rejected","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/folotyn","verifiedOn":"2026-09-30"},{"drugId":"porfimer-sodium","region":"EU","status":"withdrawn","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/photobarr","verifiedOn":"2026-09-30"},{"drugId":"celecoxib","region":"EU","status":"withdrawn","year":2008,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/onsenal","verifiedOn":"2026-09-30"}],"candidates":[{"region":"EU","product":"Nezglyal","inn":"leriglitazone","reason":"not-in-corpus","register":"Authorised","date":"2026-09-21","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nezglyal","indication":"Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non Gadolinium (Gd) enhancing lesions (i.e. Gd negative) in brain Magnetic Resonance Imaging (MRI), with a Neurological Functional Score (NFS) of 0 or 1."},{"region":"EU","product":"Waskyra","inn":"etuvetidigene autotemcel","reason":"not-in-corpus","register":"Authorised","date":"2026-01-09","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/waskyra","indication":"Waskyra is indicated for the treatment of patients aged 6 months and older with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom haematopoietic stem cell (HSC) transplantation is appropriate and no suitable human leukocyte antigen (HLA)-matched related haematopoietic stem "},{"region":"EU","product":"Lynkuet","inn":"elinzanetant","reason":"not-in-corpus","register":"Authorised","date":"2025-11-17","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lynkuet","indication":"Treatment of moderate to severe vasomotor symptoms (VMS)."},{"region":"EU","product":"Casgevy","inn":"exagamglogene autotemcel","reason":"not-in-corpus","register":"Authorised","date":"2024-02-09","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/casgevy","indication":"β thalassemia Casgevy is indicated for the treatment of transfusion dependent β thalassemia (TDT) in patients 12 years of age and older for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available. Sickle cell d","supportive":true},{"region":"EU","product":"Libmeldy","inn":"autologous CD34+ cells encoding ARSA gene","reason":"not-in-corpus","register":"Authorised","date":"2020-12-17","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/libmeldy","indication":"Libmeldy is indicated for the treatment of metachromatic leukodystrophy (MLD) characterized by biallelic mutations in the arysulfatase A (ARSA) gene leading to a reduction of the ARSA enzymatic activity:  in children with late infantile or early juvenile forms, without clinical manifestations of the"},{"region":"EU","product":"Lumeblue (previously Methylthioninium chloride Cosmo)","inn":"methylthioninium chloride","reason":"not-in-corpus","register":"Authorised","date":"2020-08-19","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lumeblue","indication":"Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy."},{"region":"EU","product":"Xromi","inn":"hydroxycarbamide","reason":"not-in-corpus","register":"Authorised","date":"2019-07-01","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xromi","indication":"Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age."},{"region":"EU","product":"SomaKit TOC","inn":"edotreotide","reason":"not-in-corpus","register":"Authorised","date":"2016-12-08","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/somakit-toc","indication":"This medicinal product is for diagnostic use only. After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or s"},{"region":"EU","product":"Strimvelis","inn":"autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence","reason":"not-in-corpus","register":"Authorised","date":"2016-05-26","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/strimvelis","indication":"Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available (see section 4.2 and section 4.4)."},{"region":"EU","product":"Entyvio","inn":"vedolizumab","reason":"not-in-corpus","register":"Authorised","date":"2014-05-22","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio","indication":"Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s"},{"region":"EU","product":"Procysbi","inn":"mercaptamine","reason":"not-in-corpus","register":"Authorised","date":"2013-09-05","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/procysbi","indication":"Procysbi is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure."},{"region":"EU","product":"NeoRecormon","inn":"epoetin beta","reason":"not-in-corpus","register":"Authorised","date":"1997-07-16","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/neorecormon","indication":"Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients; treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy; increasing the yield of autologous blood from patients in a pre-donation programme. ","supportive":true},{"region":"EU","product":"Cystagon","inn":"mercaptamine bitartrate","reason":"not-in-corpus","register":"Authorised","date":"1997-06-23","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cystagon","indication":"Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure."},{"region":"EU","product":"Yartemlea","inn":"Narsoplimab","reason":"not-in-corpus","register":"Opinion under re-examination","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/yartemlea","indication":"Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy "},{"region":"EU","drugId":"filgrastim","product":"Zefylti","inn":"filgrastim","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti-0","indication":"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 syndromes) and for the reduction in the durat","reason":"missing-row","register":"Application withdrawn","supportive":true}],"errors":[],"sources":{"ema":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx","mhra":{"url":"https://products.mhra.gov.uk/","note":"MHRA's products site has no documented public API; UK rows stay hand-verified against the SmPC search."},"pmda":{"url":"https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html","note":"PMDA publishes its list of approved products as PDF only; Japanese rows stay hand-verified."}}}