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"active_substances": "human normal immunoglobulin (IVIg)", "dhpc_type": "Quality defect", "regulatory_outcome": "", "referral_name": "", "atc_code_human": "J06BA02", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Purpura;Bone Marrow Transplantation;Immunologic Deficiency Syndromes;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "22/08/2024", "first_published_date": "22/08/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/privigen" }, { "category": "Human", "name_of_medicine": "NovoSeven", "procedure_number": "EMEA/H/C/000074", "active_substances": "eptacog alfa (activated)", "dhpc_type": "Medicine shortage;Quality defect", "regulatory_outcome": "", "referral_name": "", "atc_code_human": "B02BD08", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Hemophilia B;Thrombasthenia;Factor VII Deficiency;Hemophilia A", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "19/08/2024", "first_published_date": "19/08/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/novoseven" }, { "category": "Human", "name_of_medicine": "Glatiramer acetate", "procedure_number": "PSUSA/00001529/202311", "active_substances": "Glatiramer acetate", "dhpc_type": "Adverse event", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L03AX13", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Multiple Sclerosis", "species": "", "other_related_medicines_nationally_authorised": "Glatiramer acetate", "dissemination_date": "14/08/2024", "first_published_date": "14/08/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/glatiramer-acetate" }, { "category": "Human", "name_of_medicine": "Ocaliva", "procedure_number": "", "active_substances": "obeticholic acid", "dhpc_type": "Post-authorisation measure", 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"Veterinary", "name_of_medicine": "Senvelgo", "procedure_number": "EMEA/V/C/005972", "active_substances": "velagliflozin L-proline monohydrate", "dhpc_type": "Adverse event", "regulatory_outcome": "", "referral_name": "", "atc_code_human": "", "atcvet_code_veterinary": "QA10BK90", "therapeutic_area_mesh": "", "species": "Cats", "other_related_medicines_nationally_authorised": "", "dissemination_date": "19/07/2024", "first_published_date": "19/07/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/senvelgo" }, { "category": "Human", "name_of_medicine": "Abecma / Breyanzi / Carvykti / Kymriah / Tecartus / Yescarta", "procedure_number": "", "active_substances": "idecabtagene vicleucel;lisocabtagene maraleucel;tisagenlecleucel;brexucabtagene autoleucel;axicabtagene ciloleucel;ciltacabtagene autoleucel", "dhpc_type": "Adverse event", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L01;L01XL05;L01XL04;L01X;L01XX70", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Multiple Myeloma;Lymphoma, Large B-Cell, Diffuse;Lymphoma, Follicular;Mediastinal Neoplasms;Precursor B-Cell Lymphoblastic Leukemia-Lymphoma;Lymphoma, Mantle-Cell", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "18/07/2024", "first_published_date": "18/07/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/abecma-breyanzi-carvykti-kymriah-tecartus-yescarta" }, { "category": "Human", "name_of_medicine": "Hydroxyprogesterone caproate", "procedure_number": "EMEA-H-A-31-1528", "active_substances": "hydroxyprogesterone caproate", "dhpc_type": "Post-authorisation measure", "regulatory_outcome": "Suspension", "referral_name": "Hydroxyprogesterone caproate-containing medicinal products", "atc_code_human": "", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "", "species": "", "other_related_medicines_nationally_authorised": "Lentogest; Progesterone 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"C09", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Hypotension;Shock", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "23/05/2024", "first_published_date": "23/05/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/giapreza" }, { "category": "Human", "name_of_medicine": "Paxlovid", "procedure_number": "", "active_substances": "nirmatrelvir;ritonavir", "dhpc_type": "Adverse event", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "J05AE30", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "COVID-19 virus infection", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "21/03/2024", "first_published_date": "21/03/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/paxlovid" }, { "category": "Human", "name_of_medicine": "Valproate", "procedure_number": "EMEA/H/N/PSR/J/0043", 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"first_published_date": "08/02/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/pseudoephedrine" }, { "category": "Human", "name_of_medicine": "Voxzogo", "procedure_number": "EMEA/H/C/005475/II/0007", "active_substances": "vosoritide", "dhpc_type": "Change in dosing recommendation", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "M05BX", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Achondroplasia", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "", "first_published_date": "23/01/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/voxzogo" }, { "category": "Human", "name_of_medicine": "Leqvio", "procedure_number": "", "active_substances": "inclisiran", "dhpc_type": "Quality defect", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Hypercholesterolemia;Dyslipidemias", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "21/12/2023", "first_published_date": "23/01/2024", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/leqvio" }, { "category": "Human", "name_of_medicine": "Integrilin", "procedure_number": "", "active_substances": "eptifibatide", "dhpc_type": "Medicine shortage", "regulatory_outcome": "Withdrawal", "referral_name": "", "atc_code_human": "B01AC16", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Angina, Unstable;Myocardial Infarction", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "02/11/2023", "first_published_date": "04/12/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/integrilin" }, { "category": "Human", "name_of_medicine": "Ozempic / Victoza", "procedure_number": "", "active_substances": "semaglutide;liraglutide", "dhpc_type": "Medicine shortage", "regulatory_outcome": "", "referral_name": "", "atc_code_human": "A10BJ06;A10BJ02", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "", "first_published_date": "21/11/2023", "last_updated_date": "01/12/2023", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/ozempic-victoza" }, { "category": "Human", "name_of_medicine": "Omega-3 fatty acid ethyl esters", "procedure_number": "", "active_substances": "omega-3 fatty acid ethyl esters", "dhpc_type": "Adverse event", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Cardiovascular Diseases", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "08/11/2023", "first_published_date": "01/12/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/omega-3-fatty-acid-ethyl-esters" }, { "category": "Human", "name_of_medicine": "Topiramate / phentermine", "procedure_number": "EMEA/H/A-31/1520", "active_substances": "topiramate;phentermine", "dhpc_type": "Restriction of indication", "regulatory_outcome": "Variation", "referral_name": "Topiramate", "atc_code_human": "N03AX11", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Epilepsy;Migraine Disorders", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "01/11/2023", "first_published_date": "21/11/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/topiramate-phentermine" }, { "category": "Human", "name_of_medicine": "Vaxneuvance", "procedure_number": "", "active_substances": "Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)", "dhpc_type": "Quality defect", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "J07AL02", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Pneumococcal Infections", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "20/09/2023", "first_published_date": "20/09/2023", "last_updated_date": "20/09/2023", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/vaxneuvance" }, { "category": "Human", "name_of_medicine": "RoActemra / Hemlibra / Herceptin / Kadcyla / MabThera / Phesgo / Tecentriq", "procedure_number": "", "active_substances": "tocilizumab;emicizumab;trastuzumab;trastuzumab emtansine;rituximab;pertuzumab;trastuzumab;atezolizumab", "dhpc_type": "Quality defect", "regulatory_outcome": "", "referral_name": "", "atc_code_human": "L04AC07;B02BX06;L01XC03;L01XC14;L01XC02;L01XY", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Cytokine Release Syndrome;Giant Cell Arteritis;COVID-19 virus infection;Hemophilia A;Stomach Neoplasms;Breast Neoplasms;Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell;Carcinoma, Transitional Cell;Carcinoma, Non-Small-Cell Lung;Urologic Neoplasms;Small Cell Lung Carcinoma", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "17/08/2023", "first_published_date": "17/08/2023", "last_updated_date": "17/08/2023", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/roactemra-hemlibra-herceptin-kadcyla-mabthera-phesgo-tecentriq" }, { "category": "Human", "name_of_medicine": "Advate / Rixubis", "procedure_number": "", "active_substances": "octocog alfa;Factor VIII Inhibitor Bypassing Activity;nonacog gamma", "dhpc_type": "Quality defect", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "14/08/2023", "first_published_date": "14/08/2023", "last_updated_date": "14/08/2023", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/advate-rixubis" }, { "category": "Human", "name_of_medicine": "Simponi", "procedure_number": "", "active_substances": "golimumab", "dhpc_type": "Quality defect", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L04AB06", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Arthritis, Rheumatoid", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "09/08/2023", "first_published_date": "10/08/2023", "last_updated_date": "10/08/2023", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/simponi" }, { "category": "Human", "name_of_medicine": "Gavreto", "procedure_number": "EMEA/H/C/005413", "active_substances": "pralsetinib", "dhpc_type": "Adverse event;Post-authorisation measure", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "16/06/2023", "first_published_date": "16/06/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/gavreto" }, { "category": "Human", "name_of_medicine": "Adakveo", "procedure_number": "EMEA/H/A-20/1525/C/4874/0013", "active_substances": "Crizanlizumab", "dhpc_type": "Lack of effect;Referral - Article 20 procedure", "regulatory_outcome": "Revocation", "referral_name": "", "atc_code_human": "B06AX01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Anemia, Sickle Cell", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "15/06/2023", "first_published_date": "15/06/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/adakveo-0" }, { "category": "Human", "name_of_medicine": "Fluoroquinolones", "procedure_number": 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"Human", "name_of_medicine": "Caprelsa", "procedure_number": "EMEA/H/C/002315/II/0043", "active_substances": "vandetanib", "dhpc_type": "Restriction of indication", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Thyroid Neoplasms", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "", "first_published_date": "28/02/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/caprelsa" }, { "category": "Human", "name_of_medicine": "Xalkori", "procedure_number": "EMEA/H/C/002489/II/0072", "active_substances": "crizotinib", "dhpc_type": "Adverse event", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L01ED01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "", 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"name_of_medicine": "Adakveo", "procedure_number": "EMEA/H/C/004874", "active_substances": "Crizanlizumab", "dhpc_type": "Referral - Article 20 procedure", "regulatory_outcome": "", "referral_name": "Adakveo", "atc_code_human": "B06AX01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Anemia, Sickle Cell", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "14/02/2023", "first_published_date": "14/02/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/adakveo" }, { "category": "Human", "name_of_medicine": "Amfepramone", "procedure_number": "EMEA/H/A-31/1501", "active_substances": "amfepramone", "dhpc_type": "Referral - Article 31", "regulatory_outcome": "Revocation", "referral_name": "Amfepramone-containing medicinal products", "atc_code_human": "A08AA03", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Obesity", "species": "", "other_related_medicines_nationally_authorised": "Regenon; Tenuate 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"atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Breast Neoplasms", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "24/01/2023", "first_published_date": "25/01/2023", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/pazenir" }, { "category": "Human", "name_of_medicine": "Insuman", "procedure_number": "EMEA/H/C/000201", "active_substances": "insulin human", "dhpc_type": "Medicine shortage", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "A10AB01;A10AC01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Diabetes Mellitus", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "14/01/2023", "first_published_date": "16/01/2023", "last_updated_date": "16/01/2023", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/insuman-0" }, { "category": "Human", "name_of_medicine": "Zoely", "procedure_number": "EMEA/H/A-31/1510", "active_substances": "nomegestrol;chlormadinone", "dhpc_type": "Adverse event;Referral - Article 31", "regulatory_outcome": "Variation", "referral_name": "Nomegestrol and chlormadinone", "atc_code_human": "G03", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "08/11/2022", "first_published_date": "08/11/2022", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/zoely" }, { "category": "Human", "name_of_medicine": "Imbruvica", "procedure_number": "EMEA/H/C/003791/II/0075", "active_substances": "Ibrutinib", "dhpc_type": "Post-authorisation measure", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "L01EL01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, Chronic, B-Cell", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": 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"therapeutic_area_mesh": "Hypoparathyroidism", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "04/10/2022", "first_published_date": "04/10/2022", "last_updated_date": "04/10/2022", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/natpar-0" }, { "category": "Human", "name_of_medicine": "Nulojix", "procedure_number": "EMEA/H/C/002098", "active_substances": "belatacept", "dhpc_type": "Medicine shortage", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "L04AA28", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Graft Rejection;Kidney Transplantation", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "28/09/2022", "first_published_date": "27/09/2022", "last_updated_date": "28/09/2022", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/nulojix-2" }, { "category": "Human", "name_of_medicine": "Metalyse", "procedure_number": "EMEA/H/C/000306", "active_substances": "tenecteplase", "dhpc_type": "Medicine shortage", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "B01AD11", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Myocardial Infarction", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "23/09/2022", "first_published_date": "23/09/2022", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/metalyse" }, { "category": "Human", "name_of_medicine": "Nulojix", "procedure_number": "EMEA/H/C/002098/II/0079/G", "active_substances": "belatacept", "dhpc_type": "Medication error", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "L04AA28", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Graft Rejection;Kidney Transplantation", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "12/09/2022", "first_published_date": "12/09/2022", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/nulojix-1" }, { "category": "Human", "name_of_medicine": "Visudyne", "procedure_number": "EMEA/H/C/000305", "active_substances": "verteporfin", "dhpc_type": "Medicine shortage", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "S01LA01", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Myopia, Degenerative;Macular Degeneration", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "12/08/2022", "first_published_date": "12/08/2022", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/visudyne-0" }, { "category": "Veterinary", "name_of_medicine": "Hiprabovis IBR Marker Live", "procedure_number": "EMEA/V/C/000158", "active_substances": "live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50", "dhpc_type": "Adverse event", "regulatory_outcome": "Variation", "referral_name": "", "atc_code_human": "", "atcvet_code_veterinary": "QI02AD01", "therapeutic_area_mesh": "", "species": "Cattle", "other_related_medicines_nationally_authorised": "", "dissemination_date": "11/08/2022", "first_published_date": "11/08/2022", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/hiprabovis-ibr-marker-live" }, { "category": "Human", "name_of_medicine": "Cetrotide", "procedure_number": "EMEA/H/C/000233", "active_substances": "cetrorelix (as acetate)", "dhpc_type": "Medicine shortage", "regulatory_outcome": "Maintenance", "referral_name": "", "atc_code_human": "H01CC02", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Ovulation;Ovulation Induction", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "09/08/2022", "first_published_date": "09/08/2022", "last_updated_date": "09/08/2022", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/cetrotide" }, { "category": "Human", "name_of_medicine": "Rubraca", "procedure_number": "EMEA/H/A-20/1518/C/4272/0033", "active_substances": "rucaparib camsylate", "dhpc_type": "Referral - Article 20 procedure;Restriction of indication", "regulatory_outcome": "Variation", "referral_name": "Rubraca", "atc_code_human": "L01XX", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "Ovarian Neoplasms", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "12/08/2022", "first_published_date": "08/08/2022", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/rubraca" }, { "category": "Human", "name_of_medicine": "Hydroxyethyl starch", "procedure_number": "", "active_substances": "hydroxyethyl starch", "dhpc_type": "Post-authorisation measure", "regulatory_outcome": "Suspension", "referral_name": "Hydroxyethyl starch (HES) containing medicinal products", "atc_code_human": "", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "", "species": "", 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"Human", "name_of_medicine": "Xeloda / Capecitabine Accord / Capecitabine Medac / Capecitabine Teva / Ecansya (previously Capecitabine Krka) / Teysuno", "procedure_number": "EMEA/H/A-31/1488", "active_substances": "Fluorouracil;capecitabine;tegafur", "dhpc_type": "Referral - Article 31", "regulatory_outcome": "Variation", "referral_name": "Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products", "atc_code_human": "L01BC06;L01BC53;L01BC02", "atcvet_code_veterinary": "", "therapeutic_area_mesh": "", "species": "", "other_related_medicines_nationally_authorised": "", "dissemination_date": "04/06/2020", "first_published_date": "04/06/2020", "last_updated_date": "", "dhpc_url": "https://www.ema.europa.eu/en/medicines/dhpc/xeloda-capecitabine-accord-capecitabine-medac-capecitabine-teva-ecansya-previously-capecitabine-krka-teysuno" }, { "category": "Human", "name_of_medicine": "Tepadina", "procedure_number": "", 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