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oved","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tukysa","verifiedOn":"2026-09-09"},{"drugId":"zanubrutinib","region":"EU","status":"approved","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa","verifiedOn":"2026-09-09"},{"drugId":"everolimus","region":"EU","status":"approved","year":2009,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/afinitor","verifiedOn":"2026-09-09"},{"drugId":"binimetinib","region":"EU","status":"approved","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mektovi","verifiedOn":"2026-09-09"},{"drugId":"futibatinib","region":"EU","status":"conditional","year":2023,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi","verifiedOn":"2026-09-09"},{"drugId":"pazopanib","region":"EU","status":"approved","year":2010,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/votrient","verifiedOn":"2026-09-09"},{"drugId":"tagraxofusp","region":"EU","status":"approved","year":2021,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/elzonris","verifiedOn":"2026-09-09"},{"drugId":"glofitamab","region":"EU","status":"conditional","year":2023,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/columvi","verifiedOn":"2026-09-09"},{"drugId":"relugolix","region":"EU","status":"approved","year":2022,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/orgovyx","verifiedOn":"2026-09-09"},{"drugId":"odronextamab","region":"EU","status":"conditional","year":2024,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono","verifiedOn":"2026-09-09"},{"drugId":"gemtuzumab-ozogamicin","region":"EU","status":"approved","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mylotarg","verifiedOn":"2026-09-09"},{"drugId":"axitinib","region":"EU","status":"approved","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/inlyta","verifiedOn":"2026-09-09"},{"drugId":"talazoparib","region":"EU","status":"approved","year":2019,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/talzenna","verifiedOn":"2026-09-09"},{"drugId":"darolutamide","region":"EU","status":"approved","year":2020,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nubeqa","verifiedOn":"2026-09-09"},{"drugId":"obecabtagene-autoleucel","region":"EU","status":"conditional","year":2025,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aucatzyl","verifiedOn":"2026-09-09"},{"drugId":"linvoseltamab","region":"EU","status":"conditional","year":2025,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lynozyfic","verifiedOn":"2026-09-09"},{"drugId":"cobimetinib","region":"EU","status":"approved","year":2015,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cotellic","verifiedOn":"2026-09-09"},{"drugId":"vemurafenib","region":"EU","status":"approved","year":2012,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zelboraf","verifiedOn":"2026-09-09"},{"drugId":"neratinib","region":"EU","status":"approved","year":2018,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx","verifiedOn":"2026-09-09"},{"drugId":"panitumumab","region":"EU","status":"approved","year":2007,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vectibix","verifiedOn":"2026-09-09"},{"drugId":"repotrectinib","region":"EU","status":"conditional","year":2025,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro","verifiedOn":"2026-09-09"},{"drugId":"trifluridine-tipiracil","region":"EU","status":"approved","year":2016,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf","verifiedOn":"2026-09-09"},{"drugId":"tivozanib","region":"EU","status":"approved","year":2017,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda","verifiedOn":"2026-09-09"}],"candidates":[{"region":"EU","drugId":"camizestrant","product":"Etcamah","inn":"camizestrant","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah","indication":"Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease pr","reason":"status-mismatch","recorded":"under-review","register":"Authorised","date":"2026-07-20"},{"region":"EU","drugId":"tarlatamab","product":"Imdylltra","inn":"tarlatamab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imdylltra","indication":"Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.","reason":"status-mismatch","recorded":"under-review","register":"Authorised","date":"2026-05-29"},{"region":"EU","drugId":"lurbinectedin","product":"Zepzelca","inn":"lurbinectedin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zepzelca","indication":"Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.","reason":"status-mismatch","recorded":"under-review","register":"Authorised","date":"2026-05-29"},{"region":"EU","product":"Aumseqa","inn":"Aumolertinib","reason":"not-in-corpus","register":"Authorised","date":"2026-02-12","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aumseqa","indication":"Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult pa"},{"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":"vimseltinib","product":"Romvimza","inn":"vimseltinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/romvimza","indication":"Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.","reason":"status-mismatch","recorded":"under-review","register":"Authorised","date":"2025-09-17"},{"region":"EU","product":"Zemcelpro","inn":"allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel","reason":"not-in-corpus","register":"Authorised","date":"2025-08-25","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"},{"region":"EU","product":"Ezmekly","inn":"mirdametinib","reason":"not-in-corpus","register":"Authorised","date":"2025-07-17","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."},{"region":"EU","drugId":"imetelstat","product":"Rytelo","inn":"imetelstat","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rytelo","indication":"Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).","reason":"missing-row","register":"Authorised","date":"2025-03-07"},{"region":"EU","product":"Korjuny","inn":"catumaxomab","reason":"not-in-corpus","register":"Authorised","date":"2025-02-10","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."},{"region":"EU","product":"Cejemly","inn":"sugemalimab","reason":"not-in-corpus","register":"Authorised","date":"2024-07-24","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly","indication":"Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults with metastatic non small cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Cejemly as monotherapy is indicated for the treatmen"},{"region":"EU","drugId":"retifanlimab","product":"Zynyz","inn":"retifanlimab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz","indication":"Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC)  Z","reason":"missing-row","register":"Authorised","date":"2024-04-19"},{"region":"EU","product":"Ryzneuta","inn":"efbemalenograstim alfa","reason":"not-in-corpus","register":"Authorised","date":"2024-03-21","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)."},{"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":"sodium-thiosulfate","product":"Pedmarqsi","inn":"sodium thiosulfate","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsi","indication":"Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.","reason":"missing-row","register":"Authorised","date":"2023-05-26"},{"region":"EU","drugId":"abiraterone","product":"Akeega","inn":"niraparib;abiraterone acetate","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/akeega","indication":"Treatment of adult patients with prostate cancer.","reason":"year-mismatch","recorded":"2011","register":"authorised 2023-04-19","date":"2023-04-19"},{"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":"leuprolide","product":"Camcevi","inn":"leuprorelin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/camcevi","indication":"Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.","reason":"missing-row","register":"Authorised","date":"2022-05-24"},{"region":"EU","drugId":"pralsetinib","product":"Gavreto","inn":"pralsetinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/gavreto","indication":"Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.","reason":"status-mismatch","recorded":"approved","register":"Withdrawn","date":"2021-11-18"},{"region":"EU","product":"Koselugo","inn":"selumetinib","reason":"not-in-corpus","register":"Authorised","date":"2021-06-17","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"},{"region":"EU","drugId":"duvelisib","product":"Copiktra","inn":"duvelisib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/copiktra","indication":"Copiktra monotherapy is indicated for the treatment of adult patients with:   Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.  Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.","reason":"missing-row","register":"Withdrawn","date":"2021-05-19"},{"region":"EU","drugId":"fedratinib","product":"Inrebic","inn":"fedratinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/inrebic","indication":"Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxo","reason":"missing-row","register":"Authorised","date":"2021-02-08"},{"region":"EU","drugId":"moxetumomab-pasudotox","product":"Lumoxiti","inn":"moxetumomab pasudotox","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lumoxiti","indication":"Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (PNA).","reason":"missing-row","register":"Withdrawn","date":"2021-02-08"},{"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","drugId":"brexucabtagene-autoleucel","product":"Tecartus","inn":"brexucabtagene autoleucel","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tecartus","indication":"Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatmen","reason":"missing-row","register":"Authorised (conditional)","date":"2020-12-14"},{"region":"EU","drugId":"melphalan","product":"Phelinun","inn":"melphalan","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/phelinun","indication":"High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:  multiple myeloma, malignant lymphoma (Hodgkin, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemia, childhood neuroblastoma, ov","reason":"missing-row","register":"Authorised","date":"2020-11-16"},{"region":"EU","drugId":"pexidartinib","product":"Turalio","inn":"pexidartinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/turalio","indication":"Treatment of tenosynovial giant cell tumour.","reason":"missing-row","register":"Refused","date":"2020-10-28"},{"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","drugId":"entrectinib","product":"Rozlytrek","inn":"entrectinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrek","indication":"Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,  who have a disease that is locally advanced, metastatic or where surgical resection is likely ","reason":"missing-row","register":"Authorised (conditional)","date":"2020-07-31"},{"region":"EU","drugId":"glasdegib","product":"Daurismo","inn":"glasdegib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/daurismo","indication":"Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.","reason":"missing-row","register":"Authorised","date":"2020-06-26"},{"region":"EU","drugId":"larotrectinib","product":"Vitrakvi","inn":"larotrectinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi","indication":"Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,  who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbi","reason":"missing-row","register":"Authorised (conditional)","date":"2019-09-19"},{"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":"treosulfan","product":"Trecondi","inn":"treosulfan","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trecondi","indication":"Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.","reason":"missing-row","register":"Authorised","date":"2019-06-20"},{"region":"EU","drugId":"dacomitinib","product":"Vizimpro","inn":"dacomitinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vizimpro","indication":"Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.","reason":"missing-row","register":"Authorised","date":"2019-04-02"},{"region":"EU","drugId":"mogamulizumab","product":"Poteligeo","inn":"mogamulizumab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo","indication":"Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.","reason":"missing-row","register":"Authorised","date":"2018-11-22"},{"region":"EU","drugId":"brigatinib","product":"Alunbrig","inn":"brigatinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig","indication":"Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic l","reason":"missing-row","register":"Authorised","date":"2018-11-22"},{"region":"EU","drugId":"cytarabine-7-3","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","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","product":"Tookad","inn":"padeliporfin","reason":"not-in-corpus","register":"Authorised","date":"2017-11-10","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"},{"region":"EU","product":"Xermelo","inn":"telotristat ethyl","reason":"not-in-corpus","register":"Authorised","date":"2017-09-17","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."},{"region":"EU","drugId":"fluciclovine-f18","product":"Axumin","inn":"fluciclovine (18F)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/axumin","indication":"This medicinal product is for diagnostic use only. Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.","reason":"missing-row","register":"Authorised","date":"2017-05-21"},{"region":"EU","drugId":"methotrexate","product":"Jylamvo","inn":"methotrexate","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/jylamvo","indication":"In rheumatological and dermatological diseases  Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inad","reason":"missing-row","register":"Authorised","date":"2017-03-29"},{"region":"EU","product":"Ledaga","inn":"chlormethine","reason":"not-in-corpus","register":"Authorised","date":"2017-03-03","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."},{"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","drugId":"ixazomib","product":"Ninlaro","inn":"ixazomib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ninlaro","indication":"Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.","reason":"missing-row","register":"Authorised","date":"2016-11-21"},{"region":"EU","drugId":"irinotecan","product":"Onivyde pegylated liposomal (previously Onivyde)","inn":"irinotecan hydrochloride trihydrate","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal","indication":"ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the ","reason":"missing-row","register":"Authorised","date":"2016-10-14"},{"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":"elotuzumab","product":"Empliciti","inn":"elotuzumab","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/empliciti","indication":"Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).","reason":"missing-row","register":"Authorised","date":"2016-05-11"},{"region":"EU","product":"Neofordex","inn":"dexamethasone","reason":"not-in-corpus","register":"Authorised","date":"2016-03-16","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/neofordex","indication":"Treatment of multiple myeloma."},{"region":"EU","drugId":"asparaginase","product":"Oncaspar","inn":"pegaspargase","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/oncaspar","indication":"Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.","reason":"missing-row","register":"Authorised","date":"2016-01-14"},{"region":"EU","drugId":"panobinostat","product":"Farydak","inn":"panobinostat","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/farydak","indication":"Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. Farydak, in combination with bortezomib and d","reason":"missing-row","register":"Authorised","date":"2015-08-28"},{"region":"EU","drugId":"sonidegib","product":"Odomzo","inn":"sonidegib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/odomzo","indication":"Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.","reason":"missing-row","register":"Authorised","date":"2015-08-14"},{"region":"EU","product":"Akynzeo","inn":"netupitant;palonosetron","reason":"not-in-corpus","register":"Authorised","date":"2015-05-27","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/akynzeo","indication":"Akynzeo is indicated in adults for the:  Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy. Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy."},{"region":"EU","drugId":"ceritinib","product":"Zykadia","inn":"ceritinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zykadia","indication":"Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.","reason":"missing-row","register":"Authorised","date":"2015-05-06"},{"region":"EU","drugId":"nintedanib","product":"Vargatef","inn":"nintedanib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef","indication":"Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.","reason":"missing-row","register":"Authorised","date":"2014-11-21"},{"region":"EU","drugId":"tilmanocept-tc99m","product":"Lymphoseek","inn":"tilmanocept","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lymphoseek","indication":"This medicinal product is for diagnostic use only. Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imagin","reason":"missing-row","register":"Withdrawn","date":"2014-11-19"},{"region":"EU","drugId":"idelalisib","product":"Zydelig","inn":"idelalisib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zydelig","indication":"Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):  who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation","reason":"missing-row","register":"Authorised","date":"2014-09-18"},{"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","drugId":"cabozantinib","product":"Cometriq","inn":"cabozantinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cometriq","indication":"Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.","reason":"year-mismatch","recorded":"2016","register":"authorised 2014-03-21","date":"2014-03-21"},{"region":"EU","drugId":"afatinib","product":"Giotrif","inn":"afatinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/giotrif","indication":"Giotrif as monotherapy is indicated for the treatment of  Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing o","reason":"missing-row","register":"Authorised","date":"2013-09-25"},{"region":"EU","drugId":"sipuleucel-t","product":"Provenge","inn":"autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/provenge","indication":"Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.","reason":"missing-row","register":"Withdrawn","date":"2013-09-06"},{"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":"pomalidomide","product":"Imnovid (previously Pomalidomide Celgene)","inn":"pomalidomide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imnovid","indication":"Imnovid 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. Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with","reason":"missing-row","register":"Authorised","date":"2013-08-05"},{"region":"EU","product":"Lonquex","inn":"lipegfilgrastim","reason":"not-in-corpus","register":"Authorised","date":"2013-07-25","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)"},{"region":"EU","drugId":"vismodegib","product":"Erivedge","inn":"vismodegib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/erivedge","indication":"Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy","reason":"missing-row","register":"Authorised","date":"2013-07-12"},{"region":"EU","drugId":"bosutinib","product":"Bosulif","inn":"bosutinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bosulif","indication":"Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously tre","reason":"missing-row","register":"Authorised","date":"2013-03-27"},{"region":"EU","drugId":"romidepsin","product":"Istodax","inn":"romidepsin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/istodax","indication":"treatment of peripheral T-cell lymphoma (PTCL)","reason":"missing-row","register":"Refused","date":"2013-02-12"},{"region":"EU","product":"Zaltrap","inn":"aflibercept","reason":"not-in-corpus","register":"Authorised","date":"2013-02-01","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap","indication":"Treatment of metastatic colorectal cancer (MCRC)."},{"region":"EU","drugId":"crizotinib","product":"Xalkori","inn":"crizotinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xalkori","indication":"Xalkori as monotherapy is indicated for:  The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC","reason":"missing-row","register":"Authorised","date":"2012-10-23"},{"region":"EU","drugId":"decitabine-cedazuridine","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":"year-mismatch","recorded":"2023","register":"authorised 2012-09-20","date":"2012-09-20"},{"region":"EU","drugId":"ruxolitinib","product":"Jakavi","inn":"ruxolitinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/jakavi","indication":"Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera","reason":"missing-row","register":"Authorised","date":"2012-08-23"},{"region":"EU","drugId":"pralatrexate","product":"Folotyn","inn":"pralatrexate","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/folotyn","indication":"treatment of peripheral T-cell lymphoma","reason":"missing-row","register":"Refused","date":"2012-06-21"},{"region":"EU","product":"Sancuso","inn":"granisetron","reason":"not-in-corpus","register":"Authorised","date":"2012-04-20","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."},{"region":"EU","product":"Xaluprine (previously Mercaptopurine Nova Laboratories)","inn":"mercaptopurine","reason":"not-in-corpus","register":"Authorised","date":"2012-03-09","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."},{"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","product":"Xgeva","inn":"denosumab","reason":"not-in-corpus","register":"Authorised","date":"2011-07-13","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xgeva","indication":"Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectabl"},{"region":"EU","drugId":"eribulin","product":"Halaven","inn":"eribulin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/halaven","indication":"Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane unless patients w","reason":"missing-row","register":"Authorised","date":"2011-03-17"},{"region":"EU","product":"Teysuno","inn":"tegafur;gimeracil;oteracil","reason":"not-in-corpus","register":"Authorised","date":"2011-03-14","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"},{"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","product":"Prolia","inn":"denosumab","reason":"not-in-corpus","register":"Authorised","date":"2010-05-26","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"},{"region":"EU","product":"Tepadina","inn":"thiotepa","reason":"not-in-corpus","register":"Authorised","date":"2010-03-15","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"},{"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","product":"Javlor","inn":"vinflunine","reason":"not-in-corpus","register":"Authorised","date":"2009-09-21","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"},{"region":"EU","product":"Mozobil","inn":"plerixafor","reason":"not-in-corpus","register":"Authorised","date":"2009-07-30","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."},{"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":"gefitinib","product":"Iressa","inn":"gefitinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/iressa","indication":"Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.","reason":"missing-row","register":"Authorised","date":"2009-06-24"},{"region":"EU","drugId":"mifamurtide","product":"Mepact","inn":"mifamurtide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mepact","indication":"Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in stu","reason":"missing-row","register":"Authorised","date":"2009-03-06"},{"region":"EU","drugId":"degarelix","product":"Firmagon","inn":"degarelix","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/firmagon","indication":"FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-","reason":"missing-row","register":"Authorised","date":"2009-02-17"},{"region":"EU","product":"Ceplene","inn":"histamine dihydrochloride","reason":"not-in-corpus","register":"Authorised","date":"2008-10-07","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."},{"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","drugId":"thalidomide","product":"Thalidomide BMS (previously Thalidomide Celgene)","inn":"thalidomide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-bms","indication":"Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Progr","reason":"missing-row","register":"Authorised","date":"2008-04-16"},{"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","product":"Ivemend","inn":"fosaprepitant","reason":"not-in-corpus","register":"Authorised","date":"2008-01-11","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ivemend","indication":"Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older. Ivemend 150 mg is given as part of a combination therapy."},{"region":"EU","drugId":"paclitaxel","product":"Abraxane","inn":"paclitaxel","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/abraxane","indication":"Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-","reason":"year-mismatch","recorded":"1993","register":"authorised 2008-01-11","date":"2008-01-11"},{"region":"EU","drugId":"nilotinib","product":"Tasigna","inn":"nilotinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tasigna","indication":"Tasigna is indicated for the treatment of:  adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to p","reason":"missing-row","register":"Authorised","date":"2007-11-19"},{"region":"EU","drugId":"temsirolimus","product":"Torisel","inn":"temsirolimus","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/torisel","indication":"Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors. Mantle-cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and / or refractory ma","reason":"missing-row","register":"Authorised","date":"2007-11-19"},{"region":"EU","product":"Cervarix","inn":"human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)","reason":"not-in-corpus","register":"Authorised","date":"2007-09-20","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"},{"region":"EU","drugId":"aminolevulinic-acid-gleolan","product":"Gliolan","inn":"5-aminolevulinic acid hydrochloride","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/gliolan","indication":"Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).","reason":"missing-row","register":"Authorised","date":"2007-09-07"},{"region":"EU","product":"Atriance","inn":"nelarabine","reason":"not-in-corpus","register":"Authorised","date":"2007-08-22","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"},{"region":"EU","drugId":"hydroxyurea","product":"Siklos","inn":"hydroxycarbamide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/siklos","indication":"Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.","reason":"missing-row","register":"Authorised","date":"2007-06-29"},{"region":"EU","product":"Gardasil","inn":"human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)","reason":"not-in-corpus","register":"Authorised","date":"2006-09-20","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"},{"region":"EU","product":"Evoltra","inn":"clofarabine","reason":"not-in-corpus","register":"Authorised","date":"2006-05-29","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"},{"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":"erlotinib","product":"Tarceva","inn":"erlotinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva","indication":"Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of pat","reason":"missing-row","register":"Authorised","date":"2005-09-19"},{"region":"EU","product":"Aloxi","inn":"palonosetron","reason":"not-in-corpus","register":"Authorised","date":"2005-03-22","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"},{"region":"EU","product":"Xagrid","inn":"anagrelide","reason":"not-in-corpus","register":"Authorised","date":"2004-11-15","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"},{"region":"EU","drugId":"mitotane","product":"Lysodren","inn":"mitotane","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lysodren","indication":"Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.","reason":"missing-row","register":"Authorised","date":"2004-04-28"},{"region":"EU","drugId":"cladribine","product":"Litak","inn":"cladribine","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/litak","indication":"Litak is indicated for the treatment of hairy-cell leukaemia.","reason":"missing-row","register":"Authorised","date":"2004-04-14"},{"region":"EU","product":"Emend","inn":"aprepitant","reason":"not-in-corpus","register":"Authorised","date":"2003-11-11","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"},{"region":"EU","product":"Neulasta","inn":"pegfilgrastim","reason":"not-in-corpus","register":"Authorised","date":"2002-08-22","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)."},{"region":"EU","drugId":"arsenic-trioxide","product":"Trisenox","inn":"arsenic trioxide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trisenox","indication":"Trisenox is indicated for induction of remission, and consolidation in adult patients with:  Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/µl) in combination with all?trans?retinoic acid (ATRA) Relapsed/refractory acute promyelocytic","reason":"missing-row","register":"Authorised","date":"2002-03-05"},{"region":"EU","product":"Foscan","inn":"temoporfin","reason":"not-in-corpus","register":"Authorised","date":"2001-10-24","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."},{"region":"EU","product":"Aranesp","inn":"darbepoetin alfa","reason":"not-in-corpus","register":"Authorised","date":"2001-06-08","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."},{"region":"EU","product":"Targretin","inn":"bexarotene","reason":"not-in-corpus","register":"Authorised","date":"2001-03-29","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."},{"region":"EU","product":"Zometa","inn":"zoledronic acid","reason":"not-in-corpus","register":"Authorised","date":"2001-03-20","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"},{"region":"EU","product":"Fasturtec","inn":"rasburicase","reason":"not-in-corpus","register":"Authorised","date":"2001-02-23","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."},{"region":"EU","product":"Thyrogen","inn":"thyrotropin alfa","reason":"not-in-corpus","register":"Authorised","date":"2000-03-09","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"},{"region":"EU","product":"Beromun","inn":"tasonermin","reason":"not-in-corpus","register":"Authorised","date":"1999-04-12","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)"},{"region":"EU","drugId":"capecitabine-temozolomide","product":"Temodal","inn":"temozolomide","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/temodal","indication":"Temodal hard capsules is indicated for the treatment of:  adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as gliobla","reason":"missing-row","register":"Authorised","date":"1999-01-26"},{"region":"EU","product":"Aldara","inn":"imiquimod","reason":"not-in-corpus","register":"Authorised","date":"1998-09-18","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"},{"region":"EU","product":"Quadramet","inn":"samarium [153Sm] lexidronam pentasodium","reason":"not-in-corpus","register":"Authorised","date":"1998-02-04","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"},{"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","product":"Bondronat","inn":"ibandronic acid","reason":"not-in-corpus","register":"Authorised","date":"1996-06-25","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."},{"region":"EU","drugId":"doxorubicin","product":"Caelyx pegylated liposomal","inn":"doxorubicin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/caelyx-pegylated-liposomal","indication":"Caelyx pegylated liposomal is indicated:  as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk; for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen; in combination with bortezomib for t","reason":"year-mismatch","recorded":"1971","register":"authorised 1996-06-20","date":"1996-06-20"},{"region":"EU","product":"Fareston","inn":"toremifene","reason":"not-in-corpus","register":"Authorised","date":"1996-02-14","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."},{"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":"trastuzumab-duocarmazine","product":"Jivadco","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/jivadco","indication":"treatment of HER2 (Human Epidermal Growth Factor Receptor 2)-positive metastatic breast cancer","reason":"missing-row","register":"Application withdrawn"},{"region":"EU","drugId":"copanlisib","product":"Aliqopa","inn":"copanlisib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aliqopa","indication":"Treatment of adult patients with relapsed marginal zone lymphoma","reason":"missing-row","register":"Application withdrawn"},{"region":"EU","drugId":"mobocertinib","product":"Exkivity","inn":"mobocertinib","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/exkivity","indication":"Treatment of adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).","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."}}}