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proved","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/phelinun","verifiedOn":"2026-09-16"},{"drugId":"sodium-thiosulfate","region":"EU","status":"approved","year":2023,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsi","verifiedOn":"2026-09-16"},{"drugId":"neratinib","region":"EU","status":"approved","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx","verifiedOn":"2026-09-16"},{"drugId":"imetelstat","region":"EU","status":"approved","year":2025,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rytelo","verifiedOn":"2026-09-16"},{"drugId":"panitumumab","region":"EU","status":"approved","year":2007,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vectibix","verifiedOn":"2026-09-16"},{"drugId":"glasdegib","region":"EU","status":"approved","year":2020,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/daurismo","verifiedOn":"2026-09-16"},{"drugId":"brigatinib","region":"EU","status":"approved","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig","verifiedOn":"2026-09-16"},{"drugId":"cladribine","region":"EU","status":"approved","year":2004,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/litak","verifiedOn":"2026-09-16"},{"drugId":"erlotinib","region":"EU","status":"approved","year":2005,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva","verifiedOn":"2026-09-16"},{"drugId":"temsirolimus","region":"EU","status":"approved","year":2007,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/torisel","verifiedOn":"2026-09-16"},{"drugId":"repotrectinib","region":"EU","status":"conditional","year":2025,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro","verifiedOn":"2026-09-16"},{"drugId":"pralsetinib","region":"EU","status":"withdrawn","year":2024,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/gavreto","verifiedOn":"2026-09-16"},{"drugId":"dacomitinib","region":"EU","status":"approved","year":2019,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vizimpro","verifiedOn":"2026-09-16"},{"drugId":"irinotecan","region":"EU","status":"approved","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal","verifiedOn":"2026-09-16"},{"drugId":"idelalisib","region":"EU","status":"approved","year":2014,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zydelig","verifiedOn":"2026-09-16"},{"drugId":"gefitinib","region":"EU","status":"approved","year":2009,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/iressa","verifiedOn":"2026-09-16"},{"drugId":"tilmanocept-tc99m","region":"EU","status":"withdrawn","year":2024,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lymphoseek","verifiedOn":"2026-09-16"},{"drugId":"trifluridine-tipiracil","region":"EU","status":"approved","year":2016,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf","verifiedOn":"2026-09-16"},{"drugId":"tivozanib","region":"EU","status":"approved","year":2017,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda","verifiedOn":"2026-09-16"},{"drugId":"moxetumomab-pasudotox","region":"EU","status":"withdrawn","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lumoxiti","verifiedOn":"2026-09-16"},{"drugId":"pexidartinib","region":"EU","status":"withdrawn","year":2020,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/turalio","verifiedOn":"2026-09-16"},{"drugId":"sipuleucel-t","region":"EU","status":"withdrawn","year":2015,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/provenge","verifiedOn":"2026-09-16"},{"drugId":"romidepsin","region":"EU","status":"withdrawn","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/istodax","verifiedOn":"2026-09-16"},{"drugId":"pralatrexate","region":"EU","status":"rejected","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/folotyn","verifiedOn":"2026-09-16"}],"candidates":[{"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","drugId":"dorocubicel","product":"Zemcelpro","inn":"allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zemcelpro","indication":"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","reason":"missing-row","register":"Authorised (conditional)","date":"2025-08-25"},{"region":"EU","drugId":"mirdametinib","product":"Ezmekly","inn":"mirdametinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ezmekly","indication":"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.","reason":"missing-row","register":"Authorised (conditional)","date":"2025-07-17"},{"region":"EU","drugId":"catumaxomab","product":"Korjuny","inn":"catumaxomab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny","indication":"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.","reason":"missing-row","register":"Authorised","date":"2025-02-10"},{"region":"EU","drugId":"efbemalenograstim-alfa","product":"Ryzneuta","inn":"efbemalenograstim alfa","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ryzneuta","indication":"Ryzneuta is indicated for the 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).","reason":"missing-row","register":"Authorised","date":"2024-03-21"},{"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"},{"region":"EU","product":"Pylclari","inn":"piflufolastat (18F)","reason":"not-in-corpus","register":"Authorised","date":"2023-11-27","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pylclari","indication":"This medicinal product is for diagnostic use only. Pylclari is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:  Primary staging of patients with "},{"region":"EU","product":"Enrylaze","inn":"crisantaspase","reason":"not-in-corpus","register":"Authorised","date":"2023-09-15","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/enrylaze","indication":"Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived aspar"},{"region":"EU","drugId":"melflufen","product":"Pepaxti","inn":"melphalan flufenamide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pepaxti","indication":"Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal ant","reason":"missing-row","register":"Authorised","date":"2022-08-17"},{"region":"EU","drugId":"capmatinib","product":"Tabrecta","inn":"capmatinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tabrecta","indication":"Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunother","reason":"missing-row","register":"Authorised","date":"2022-06-20"},{"region":"EU","drugId":"tepotinib","product":"Tepmetko","inn":"tepotinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko","indication":"Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immun","reason":"missing-row","register":"Authorised","date":"2022-02-16"},{"region":"EU","drugId":"selumetinib","product":"Koselugo","inn":"selumetinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/koselugo","indication":"Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neur","reason":"missing-row","register":"Authorised (conditional)","date":"2021-06-17"},{"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","drugId":"daunorubicin","product":"Vyxeos liposomal (previously Vyxeos)","inn":"daunorubicin;cytarabine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vyxeos-liposomal","indication":"Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).","reason":"missing-row","register":"Authorised","date":"2018-08-23"},{"region":"EU","drugId":"carmustine","product":"Carmustine medac (previously Carmustine Obvius)","inn":"carmustine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/carmustine-medac","indication":"Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):  Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), b","reason":"missing-row","register":"Authorised","date":"2018-07-18"},{"region":"EU","product":"Crysvita","inn":"burosumab","reason":"not-in-corpus","register":"Authorised","date":"2018-02-19","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/crysvita","indication":"Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with p"},{"region":"EU","drugId":"padeliporfin","product":"Tookad","inn":"padeliporfin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tookad","indication":"Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and:  Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer co","reason":"missing-row","register":"Authorised","date":"2017-11-10"},{"region":"EU","drugId":"telotristat-ethyl","product":"Xermelo","inn":"telotristat ethyl","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xermelo","indication":"Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.","reason":"missing-row","register":"Authorised","date":"2017-09-17"},{"region":"EU","drugId":"rolapitant","product":"Varuby","inn":"rolapitant","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/varuby","indication":"Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.Varuby is given as part of combination therapy.","reason":"missing-row","register":"Withdrawn","date":"2017-04-19"},{"region":"EU","drugId":"mechlorethamine","product":"Ledaga","inn":"chlormethine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ledaga","indication":"Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.","reason":"missing-row","register":"Authorised","date":"2017-03-03"},{"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","drugId":"dexamethasone","product":"Neofordex","inn":"dexamethasone","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/neofordex","indication":"Treatment of multiple myeloma.","reason":"missing-row","register":"Authorised","date":"2016-03-16"},{"region":"EU","drugId":"necitumumab","product":"Portrazza","inn":"necitumumab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza","indication":"Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition","reason":"missing-row","register":"Withdrawn","date":"2016-02-15"},{"region":"EU","drugId":"trametinib","product":"Mekinist","inn":"trametinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mekinist","indication":"Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Trametinib monotherapy has not demo","reason":"missing-row","register":"Authorised","date":"2014-06-30"},{"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","drugId":"dabrafenib","product":"Tafinlar","inn":"dabrafenib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tafinlar","indication":"Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combinatio","reason":"missing-row","register":"Authorised","date":"2013-08-26"},{"region":"EU","drugId":"lipegfilgrastim","product":"Lonquex","inn":"lipegfilgrastim","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex","indication":"Lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)","reason":"missing-row","register":"Authorised","date":"2013-07-25"},{"region":"EU","drugId":"ziv-aflibercept","product":"Zaltrap","inn":"aflibercept","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap","indication":"Treatment of metastatic colorectal cancer (MCRC).","reason":"missing-row","register":"Authorised","date":"2013-02-01"},{"region":"EU","drugId":"decitabine","product":"Dacogen","inn":"decitabine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/dacogen","indication":"Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.","reason":"missing-row","register":"Authorised","date":"2012-09-20"},{"region":"EU","drugId":"granisetron","product":"Sancuso","inn":"granisetron","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sancuso","indication":"Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days. Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.","reason":"missing-row","register":"Authorised","date":"2012-04-20"},{"region":"EU","drugId":"mercaptopurine","product":"Xaluprine (previously Mercaptopurine Nova Laboratories)","inn":"mercaptopurine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xaluprine","indication":"Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.","reason":"missing-row","register":"Authorised","date":"2012-03-09"},{"region":"EU","product":"Zytiga","inn":"abiraterone","reason":"not-in-corpus","register":"Authorised","date":"2011-09-05","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga","indication":"Zytiga is indicated with prednisone or prednisolone for:  the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metas"},{"region":"EU","drugId":"tegafur-gimeracil-oteracil","product":"Teysuno","inn":"tegafur;gimeracil;oteracil","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/teysuno","indication":"Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1). - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer f","reason":"missing-row","register":"Authorised","date":"2011-03-14"},{"region":"EU","product":"PecFent","inn":"fentanyl","reason":"not-in-corpus","register":"Authorised","date":"2010-08-31","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pecfent","indication":"PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintena"},{"region":"EU","drugId":"denosumab","product":"Prolia","inn":"denosumab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/prolia","indication":"Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased r","reason":"missing-row","register":"Authorised","date":"2010-05-26"},{"region":"EU","drugId":"ofatumumab","product":"Arzerra","inn":"ofatumumab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra","indication":"Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Relapsed CLL: Arzerra is indicated in com","withdrawn":"2019-02-28","reason":"missing-row","register":"Withdrawn","date":"2010-04-19"},{"region":"EU","drugId":"thiotepa","product":"Tepadina","inn":"thiotepa","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tepadina","indication":"TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patien","reason":"missing-row","register":"Authorised","date":"2010-03-15"},{"region":"EU","product":"Eporatio","inn":"epoetin theta","reason":"not-in-corpus","register":"Authorised","date":"2009-10-29","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/eporatio","indication":"Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy."},{"region":"EU","product":"Biopoin","inn":"epoetin theta","reason":"not-in-corpus","register":"Authorised","date":"2009-10-23","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/biopoin","indication":"Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy."},{"region":"EU","drugId":"vinflunine","product":"Javlor","inn":"vinflunine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/javlor","indication":"Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ? 2","reason":"missing-row","register":"Authorised","date":"2009-09-21"},{"region":"EU","drugId":"plerixafor","product":"Mozobil","inn":"plerixafor","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mozobil","indication":"Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.","reason":"missing-row","register":"Authorised","date":"2009-07-30"},{"region":"EU","product":"Instanyl","inn":"fentanyl","reason":"not-in-corpus","register":"Authorised","date":"2009-07-20","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/instanyl","indication":"Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.  Patients receiving maintenance op"},{"region":"EU","drugId":"histamine-dihydrochloride","product":"Ceplene","inn":"histamine dihydrochloride","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene","indication":"Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.","reason":"missing-row","register":"Authorised","date":"2008-10-07"},{"region":"EU","product":"Privigen","inn":"human normal immunoglobulin (IVIg)","reason":"not-in-corpus","register":"Authorised","date":"2008-04-24","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/privigen","indication":"Replacement therapy in adults, and children and adolescents (0-18 years) in:  primary immunodeficiency (PID) syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have fa"},{"region":"EU","product":"Effentora","inn":"fentanyl","reason":"not-in-corpus","register":"Authorised","date":"2008-04-04","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/effentora","indication":"Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving mai"},{"region":"EU","drugId":"epoetin-alfa","product":"Retacrit","inn":"epoetin zeta","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit","indication":"Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:  treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal","reason":"missing-row","register":"Authorised","date":"2007-12-18"},{"region":"EU","drugId":"hpv-bivalent-vaccine","product":"Cervarix","inn":"human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cervarix","indication":"Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information o","reason":"missing-row","register":"Authorised","date":"2007-09-20"},{"region":"EU","drugId":"nelarabine","product":"Atriance","inn":"nelarabine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/atriance","indication":"Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in th","reason":"missing-row","register":"Authorised","date":"2007-08-22"},{"region":"EU","drugId":"hpv-quadrivalent-vaccine","product":"Gardasil","inn":"human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil","indication":"Gardasil is a vaccine for use from the age of 9 years for the prevention of:  premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acu","reason":"missing-row","register":"Authorised","date":"2006-09-20"},{"region":"EU","drugId":"clofarabine","product":"Evoltra","inn":"clofarabine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/evoltra","indication":"Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patie","reason":"missing-row","register":"Authorised","date":"2006-05-29"},{"region":"EU","product":"Kiovig","inn":"human normal immunoglobulin","reason":"not-in-corpus","register":"Authorised","date":"2006-01-19","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kiovig","indication":"Replacement therapy in adults, and children and adolescents (0-18 years) in:  primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; "},{"region":"EU","drugId":"palonosetron","product":"Aloxi","inn":"palonosetron","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aloxi","indication":"Aloxi is indicated in adults for:  the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.  Aloxi is indicated in paediatric patients 1 month of age and older f","reason":"missing-row","register":"Authorised","date":"2005-03-22"},{"region":"EU","drugId":"anagrelide","product":"Xagrid","inn":"anagrelide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xagrid","indication":"Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at-risk patient An at-risk ET is def","reason":"missing-row","register":"Authorised","date":"2004-11-15"},{"region":"EU","drugId":"ibritumomab-tiuxetan","product":"Zevalin","inn":"ibritumomab tiuxetan","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zevalin","indication":"Zevalin is indicated in adults. [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabe","withdrawn":"2024-01-04","reason":"missing-row","register":"Lapsed","date":"2004-01-16"},{"region":"EU","drugId":"aprepitant","product":"Emend","inn":"aprepitant","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/emend","indication":"Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adol","reason":"missing-row","register":"Authorised","date":"2003-11-11"},{"region":"EU","drugId":"busulfan","product":"Busilvex","inn":"busulfan","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/busilvex","indication":"Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex following fludarabine (FB) is indicated as conditi","reason":"missing-row","register":"Withdrawn","date":"2003-07-09"},{"region":"EU","drugId":"pegfilgrastim","product":"Neulasta","inn":"pegfilgrastim","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta","indication":"Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).","reason":"missing-row","register":"Authorised","date":"2002-08-22"},{"region":"EU","drugId":"temoporfin","product":"Foscan","inn":"temoporfin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/foscan","indication":"Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.","reason":"missing-row","register":"Authorised","date":"2001-10-24"},{"region":"EU","drugId":"cytarabine","product":"DepoCyte","inn":"cytarabine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/depocyte","indication":"Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.","reason":"missing-row","register":"Withdrawn","date":"2001-07-11"},{"region":"EU","drugId":"alemtuzumab","product":"MabCampath","inn":"alemtuzumab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mabcampath","indication":"MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.","withdrawn":"2012-08-08","reason":"missing-row","register":"Withdrawn","date":"2001-07-06"},{"region":"EU","drugId":"darbepoetin-alfa","product":"Aranesp","inn":"darbepoetin alfa","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aranesp","indication":"Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.","reason":"missing-row","register":"Authorised","date":"2001-06-08"},{"region":"EU","drugId":"bexarotene","product":"Targretin","inn":"bexarotene","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/targretin","indication":"Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.","reason":"missing-row","register":"Authorised","date":"2001-03-29"},{"region":"EU","drugId":"zoledronic-acid","product":"Zometa","inn":"zoledronic acid","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zometa","indication":"Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathologi","reason":"missing-row","register":"Authorised","date":"2001-03-20"},{"region":"EU","drugId":"rasburicase","product":"Fasturtec","inn":"rasburicase","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fasturtec","indication":"Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.","reason":"missing-row","register":"Authorised","date":"2001-02-23"},{"region":"EU","drugId":"capecitabine","product":"Xeloda","inn":"capecitabine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xeloda","indication":"Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for the treatment of metastatic colorectal cancer. Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based","reason":"missing-row","register":"Authorised","date":"2001-02-02"},{"region":"EU","drugId":"thyrotropin-alfa","product":"Thyrogen","inn":"thyrotropin alfa","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/thyrogen","indication":"Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST).   Low risk patients with wel","reason":"missing-row","register":"Authorised","date":"2000-03-09"},{"region":"EU","drugId":"tasonermin","product":"Beromun","inn":"tasonermin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/beromun","indication":"Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ILP)","reason":"missing-row","register":"Authorised","date":"1999-04-12"},{"region":"EU","drugId":"imiquimod","product":"Aldara","inn":"imiquimod","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aldara","indication":"Imiquimod cream is indicated for the topical treatment of :  External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immuno","reason":"missing-row","register":"Authorised","date":"1998-09-18"},{"region":"EU","drugId":"samarium-153-lexidronam","product":"Quadramet","inn":"samarium [153Sm] lexidronam pentasodium","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/quadramet","indication":"Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan. The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be conf","reason":"missing-row","register":"Authorised","date":"1998-02-04"},{"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. "},{"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","drugId":"ibandronic-acid","product":"Bondronat","inn":"ibandronic acid","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bondronat","indication":"Bondronat is indicated for:  prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases; treatment of tumour-induced hypercalcaemia with or without metastases.","reason":"missing-row","register":"Authorised","date":"1996-06-25"},{"region":"EU","drugId":"toremifene","product":"Fareston","inn":"toremifene","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fareston","indication":"First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for patients with estrogen receptor negative tumours.","reason":"missing-row","register":"Authorised","date":"1996-02-14"},{"region":"EU","product":"Qezzaqar","inn":"catequentinib","reason":"not-in-corpus","register":"Opinion","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/qezzaqar","indication":"Treatment of synovial sarcoma or leiomyosarcoma."},{"region":"EU","product":"Nezglyal","inn":"leriglitazone","reason":"not-in-corpus","register":"Opinion","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nezglyal","indication":"Treatment of adrenoleukodystrophy."},{"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","product":"Tacquell","inn":"Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded","reason":"not-in-corpus","register":"Opinion","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tacquell","indication":"Treatment of melanoma "},{"region":"EU","product":"Kinselby","inn":"resminostat","reason":"not-in-corpus","register":"Opinion","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kinselby","indication":"Treatment of patients with advanced stage mycosis fungoides (MF) and Sézary syndrome (SS)"},{"region":"EU","drugId":"sasanlimab","product":"Zumrad","inn":"sasanlimab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zumrad","indication":"Treatment of bladder cancer in adults indicated for the treatment of adult indicated for treatement of bladder cancer.","reason":"missing-row","register":"Application withdrawn"},{"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"},{"region":"EU","drugId":"omacetaxine","product":"Tekinex","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tekinex","reason":"missing-row","register":"Application withdrawn"},{"region":"EU","drugId":"ixabepilone","product":"Ixempra","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ixempra","reason":"missing-row","register":"Application withdrawn"},{"region":"EU","drugId":"vorinostat","product":"Vorinostat MSD","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vorinostat-msd","reason":"missing-row","register":"Application withdrawn"}],"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."}}}