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"active_substance": "olanzapine", "status": "Authorised", "holder": "CHEPLAPHARM Registration GmbH", "atc_code": "N05AH03", "therapeutic_area": [ "Schizophrenia", "Bipolar Disorder" ], "authorisation_date": "2000-02-03", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zyprexa-velotab", "last_updated": "2024-12-18" }, { "ema_product_number": "EMEA/H/C/000292", "medicine_name": "Luveris", "inn": "lutropin alfa", "active_substance": "lutropin alfa", "status": "Authorised", "holder": "Merck Europe B.V. ", "atc_code": "G03GA07", "therapeutic_area": [ "Ovulation Induction", "Infertility, Female" ], "authorisation_date": "2000-11-29", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", 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"exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sonovue", "last_updated": "2026-03-20" }, { "ema_product_number": "EMEA/H/C/000305", "medicine_name": "Visudyne", "inn": "verteporfin", "active_substance": "verteporfin", "status": "Authorised", "holder": "CHEPLAPHARM Arzneimittel GmbH", "atc_code": "S01LA01", "therapeutic_area": [ "Myopia, Degenerative", "Macular Degeneration" ], "authorisation_date": "2000-07-27", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/visudyne", "last_updated": "2020-09-16" }, { "ema_product_number": "EMEA/H/C/000306", "medicine_name": "Metalyse", "inn": "tenecteplase", "active_substance": "tenecteplase", "status": "Authorised", "holder": "Boehringer Ingelheim International GmbH", "atc_code": "B01AD11", "therapeutic_area": [ "Myocardial Infarction" ], "authorisation_date": "2001-02-23", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/metalyse", "last_updated": "2026-07-21" }, { "ema_product_number": "EMEA/H/C/000307", "medicine_name": "Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG", "inn": "tenecteplase", "active_substance": "tenecteplase", "status": "Withdrawn", "holder": "Boehringer Ingelheim International GmbH", "atc_code": "B01AD", "therapeutic_area": [ "Myocardial Infarction" ], "authorisation_date": "2001-02-23", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tenecteplase-boehringer-ingelheim-pharma-gmbh-co-kg", "last_updated": "2005-12-05" }, { "ema_product_number": "EMEA/H/C/000308", "medicine_name": "NovoMix", "inn": "insulin aspart", "active_substance": "insulin aspart", "status": "Authorised", "holder": "Novo Nordisk A/S", "atc_code": "A10AD05", "therapeutic_area": [ "Diabetes Mellitus" ], "authorisation_date": "2000-08-01", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novomix", "last_updated": "2023-08-29" }, { "ema_product_number": "EMEA/H/C/000309", "medicine_name": "Toujeo (previously Optisulin)", "inn": "insulin glargine", "active_substance": "insulin glargine", "status": "Authorised", "holder": "Sanofi-aventis Deutschland GmbH", "atc_code": "A10AE04", "therapeutic_area": [ "Diabetes Mellitus" ], "authorisation_date": "2000-06-26", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/toujeo", "last_updated": "2026-03-05" }, { "ema_product_number": "EMEA/H/C/000310", "medicine_name": "Azomyr", "inn": "desloratadine", "active_substance": "desloratadine", "status": "Authorised", "holder": "Organon N.V.", "atc_code": "R06AX27", "therapeutic_area": [ "Rhinitis, Allergic, Perennial", "Urticaria", "Rhinitis, Allergic, Seasonal" ], "authorisation_date": "2001-01-15", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azomyr", "last_updated": "2026-03-02" }, { "ema_product_number": "EMEA/H/C/000311", "medicine_name": "Opulis", "inn": "desloratadine", "active_substance": "desloratadine", "status": "Withdrawn", "holder": "Schering-Plough Europe", "atc_code": "R06AX27", "therapeutic_area": [ "Rhinitis, Allergic, Perennial", "Urticaria", "Rhinitis, Allergic, Seasonal" ], "authorisation_date": "2001-01-15", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opulis", "last_updated": "2004-05-19" }, { "ema_product_number": "EMEA/H/C/000312", "medicine_name": "Allex", "inn": "desloratadine", "active_substance": "desloratadine", "status": "Withdrawn", "holder": "Schering-Plough Europe", "atc_code": "R06AX27", "therapeutic_area": [ "Rhinitis, Allergic, Perennial", "Urticaria", "Rhinitis, Allergic, Seasonal" ], "authorisation_date": "2001-01-15", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/allex", "last_updated": "2009-12-31" }, { "ema_product_number": "EMEA/H/C/000313", "medicine_name": "Aerius", "inn": "desloratadine", "active_substance": "desloratadine", "status": "Authorised", "holder": "Organon N.V.", "atc_code": "R06AX27", "therapeutic_area": [ "Rhinitis, Allergic, Perennial", "Urticaria", "Rhinitis, Allergic, Seasonal" ], "authorisation_date": "2001-01-15", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aerius", "last_updated": "2026-03-19" }, { "ema_product_number": "EMEA/H/C/000314", "medicine_name": "Neoclarityn", "inn": "desloratadine", "active_substance": "desloratadine", "status": "Authorised", "holder": "Organon N.V.", "atc_code": "R06AX27", "therapeutic_area": [ "Rhinitis, Allergic, Perennial", "Urticaria", "Rhinitis, Allergic, Seasonal" ], "authorisation_date": "2001-01-15", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neoclarityn", "last_updated": "2026-03-19" }, { "ema_product_number": "EMEA/H/C/000315", "medicine_name": "NutropinAq", "inn": "somatropin", "active_substance": "somatropin", "status": "Authorised", "holder": "Ipsen Pharma", "atc_code": "H01AC01", "therapeutic_area": [ "Turner Syndrome", "Dwarfism, Pituitary" ], "authorisation_date": "2001-02-15", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nutropinaq", "last_updated": "2023-07-20" }, { "ema_product_number": "EMEA/H/C/000316", "medicine_name": "Xeloda", "inn": "capecitabine", "active_substance": "capecitabine", "status": "Authorised", "holder": "CHEPLAPHARM Arzneimittel GmbH", "atc_code": "L01BC06", "therapeutic_area": [ "Colonic Neoplasms", "Breast Neoplasms", "Colorectal Neoplasms", "Stomach Neoplasms" ], "authorisation_date": "2001-02-02", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xeloda", "last_updated": "2025-05-02" }, { "ema_product_number": "EMEA/H/C/000317", "medicine_name": "DepoCyte", "inn": "cytarabine", "active_substance": "cytarabine", "status": "Withdrawn", "holder": "Pacira Limited", "atc_code": "L01BC01", "therapeutic_area": [ "Meningeal Neoplasms" ], "authorisation_date": "2001-07-11", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", 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"holder": "Pfizer Limited", "atc_code": "J07AL02", "therapeutic_area": [ "Pneumococcal Infections", "Immunization" ], "authorisation_date": "2001-02-02", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar", "last_updated": "2017-11-24" }, { "ema_product_number": "EMEA/H/C/000325", "medicine_name": "Vaniqa", "inn": "eflornithine", "active_substance": "eflornithine", "status": "Authorised", "holder": "Almirall, S.A.", "atc_code": "D11AX", "therapeutic_area": [ "Hirsutism" ], "authorisation_date": "2001-03-19", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaniqa", "last_updated": "2024-11-27" }, { "ema_product_number": "EMEA/H/C/000326", "medicine_name": "Targretin", "inn": "bexarotene", "active_substance": "bexarotene", "status": "Authorised", "holder": "H.A.C. 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"https://www.ema.europa.eu/en/medicines/human/EPAR/uprima", "last_updated": "2006-05-29" }, { "ema_product_number": "EMEA/H/C/000328", "medicine_name": "Ixense", "inn": "apomorphine", "active_substance": "apomorphine hydrochloride", "status": "Withdrawn", "holder": "Takeda Europe R Centre Ltd.", "atc_code": "G04BE", "therapeutic_area": [ "Erectile Dysfunction" ], "authorisation_date": "2001-05-28", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ixense", "last_updated": "2004-11-10" }, { "ema_product_number": "EMEA/H/C/000329", "medicine_name": "ViraferonPeg", "inn": "peginterferon alfa-2b", "active_substance": "peginterferon alfa-2b", "status": "Withdrawn", "holder": "Merck Sharp Dohme Ltd ", "atc_code": "L03AB10", "therapeutic_area": [ "Hepatitis C, Chronic" ], "authorisation_date": "2000-05-28", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viraferonpeg", "last_updated": "2021-01-22" }, { "ema_product_number": "EMEA/H/C/000331", "medicine_name": "Fasturtec", "inn": "rasburicase", "active_substance": "rasburicase", "status": "Authorised", "holder": "Sanofi Winthrop Industrie", "atc_code": "V03AF07", "therapeutic_area": [ "Hyperuricemia" ], "authorisation_date": "2001-02-23", "orphan": "no", "biosimilar": "no", "generic": "no", "conditional_approval": "no", "exceptional_circumstances": "no", "accelerated_assessment": "no", "prime": "no", "advanced_therapy": "no", "additional_monitoring": "no", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fasturtec", "last_updated": "2024-08-12" }, { 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