13329 results
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … Overview On 12 September 2017, Accord Healthcare Limited officially notified … authorisation for Tigecycline Accord, for the treatment of certain … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020Cabazitaxel Accord 20 mg/mL concentrate for … Direct healthcare professional communication … communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for … -
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Human medicine European public assessment report (EPAR): Repaglinide Accord
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 22/12/2011,
, Revision: 7, Authorised, Last updated: 21/01/2022
Repaglinide Accord Nutritional and Metabolic … details Name Repaglinide Accord Agency product number EMEA/H/C/002318 … Marketing-authorisation holder Accord Healthcare S.L.U. Revision 7 Date of … -
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
Dexmedetomidine Accord Therapeutics Drug Therapy … Dexmedetomidine Accord is a medicine used to sedate … sedation). Dexmedetomidine Accord contains the active substance … -
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Human medicine European public assessment report (EPAR): Teriflunomide Accord
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Authorised, Last updated: 14/11/2022
Teriflunomide Accord Multiple Sclerosis Demyelinating … Teriflunomide Accord is a medicine used to treat … themselves. Teriflunomide Accord is used in the type of MS … -
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Human medicine European public assessment report (EPAR): Pregabalin Accord
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 15, Authorised, Last updated: 09/01/2023
Pregabalin Accord Mental Disorders Nervous … report (EPAR) for Pregabalin Accord. It explains how the Agency … on how to use Pregabalin Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 30/11/2022
Lacosamide Accord Nervous System Diseases Central … report (EPAR) for Lacosamide Accord. It explains how the Agency … on how to use Lacosamide Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord
Palonosetron, Vomiting; Nausea; Cancer
Date of authorisation: 26/05/2016,, Revision: 5, Authorised, Last updated: 13/01/2022
Palonosetron Accord Pathological Conditions … report (EPAR) for Palonosetron Accord. It explains how the Agency … on how to use Palonosetron Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Tigecycline Accord
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 4, Authorised, Last updated: 29/07/2022
Tigecycline Accord Infections Bacterial Infections … Tigecycline Accord is a medicine used to treat … treatment difficult. Tigecycline Accord should be used only when … -
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 16, Authorised, Last updated: 25/04/2022
Voriconazole Accord Infections Bacterial Infections … report (EPAR) for Voriconazole Accord. It explains how the Agency … on how to use Voriconazole Accord. For practical information … -
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Summary of opinion: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Tolvaptan Accord: Pending EC decision … authorisation) Tolvaptan Accord tolvaptan On 26 January … medicinal product Tolvaptan Accord, intended for the treatment … -
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Human medicine European public assessment report (EPAR): Fampridine Accord
Fampridine, Multiple Sclerosis
Date of authorisation: 24/09/2020,, Revision: 1, Authorised, Last updated: 10/05/2022
Fampridine Accord Nervous System Diseases Autoimmune … Fampridine Accord is a medicine used to improve … and spinal cord. Fampridine Accord is a ‘generic medicine’ … -
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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … medicines are manufactured according to the same quality standards … Erlotinib Accord Erlotinib Accord erlotinib … -
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Human medicine European public assessment report (EPAR): Caspofungin Accord
caspofungin acetate, Candidiasis; Aspergillosis
Date of authorisation: 11/02/2016,, Revision: 6, Withdrawn, Last updated: 20/08/2021
Caspofungin Accord Candidiasis Aspergillosis … details Name Caspofungin Accord Agency product number EMEA/H/C/004134 … Marketing-authorisation holder Accord Healthcare S.L.U. Revision 6 Date of … -
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Human medicine European public assessment report (EPAR): Apixaban Accord
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 2, Authorised, Last updated: 19/05/2022
Apixaban Accord Thromboembolism Embolism … Apixaban Accord is a medicine used to prevent … reoccurrence. Additionally, Apixaban Accord is used to prevent stroke … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 7, Authorised, Last updated: 19/12/2022
Posaconazole Accord Infections Bacterial Infections … Posaconazole Accord is an antifungal medicine … in spores). Posaconazole Accord is also used to prevent invasive … -
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Human medicine European public assessment report (EPAR): Sitagliptin Accord
sitagliptin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 25/04/2022,, Authorised, Last updated: 21/07/2022
Sitagliptin Accord Diabetes Mellitus Glucose … Sitagliptin Accord is a medicine used to control … dose of insulin. Sitagliptin Accord contains the active substance … -
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Human medicine European public assessment report (EPAR): Lenalidomide Accord
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 9, Authorised, Last updated: 31/03/2022
Lenalidomide Accord Cancer Neoplasms Neoplasms … Lenalidomide Accord is a medicine used for the … multiple myeloma, Lenalidomide Accord is used: in adults who have … -
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Human medicine European public assessment report (EPAR): Deferasirox Accord
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,, Revision: 3, Authorised, Last updated: 08/02/2022
Deferasirox Accord Nutritional and Metabolic … Deferasirox Accord is a medicine used to treat … from the gut. Deferasirox Accord contains the active substance … -
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 22, Authorised, Last updated: 21/03/2022
Temozolomide Accord Cancer Neuroectodermal … details Name Temozolomide Accord Agency product number EMEA/H/C/001125 … Marketing-authorisation holder Accord Healthcare S.L.U. Revision 22 Date of … -
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Human medicine European public assessment report (EPAR): Pioglitazone Accord
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,, Revision: 7, Authorised, Last updated: 13/01/2022
Pioglitazone Accord Nutritional and Metabolic … report (EPAR) for Pioglitazone Accord. It explains how the Agency … on how to use Pioglitazone Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022
Imatinib Accord Neoplasms Cancer Leukemia … report (EPAR) for Imatinib Accord. It explains how the Agency … advice on how to use Imatinib Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
Aripiprazole Accord Schizophrenia Spectrum and … report (EPAR) for Aripiprazole Accord. It explains how the Agency … on how to use Aripiprazole Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Entecavir Accord
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
Entecavir Accord Infections Communicable … report (EPAR) for Entecavir Accord. It explains how the Agency … advice on how to use Entecavir Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 5, Authorised, Last updated: 13/04/2022
Eptifibatide Accord Cardiovascular Diseases Heart … report (EPAR) for Eptifibatide Accord. It explains how the Agency … on how to use Eptifibatide Accord. For practical information …