13374 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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … Overview On 12 September 2017, Accord Healthcare Limited officially notified … authorisation for Tigecycline Accord, for the treatment of certain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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Summary of opinion: Degarelix Accord
degarelix acetate, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023Degarelix Accord: Pending EC decision … medicinal product Degarelix Accord, intended for the treatment … action. medicinal product is Accord Healthcare S.L.U. Degarelix Accord will be available as an 80 … -
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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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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … medicines are manufactured according to the same quality standards … Erlotinib Accord Erlotinib Accord erlotinib … -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): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome
, Authorised, Last updated: 14/08/2023
Tolvaptan Accord Pituitary Diseases Hypothalamic … tolvaptan Overview Tolvaptan Accord is a medicine for treating … in the blood. Tolvaptan Accord is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 11, Authorised, Last updated: 22/09/2023
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): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
Cabazitaxel Accord Prostatic Neoplasms Genital … cabazitaxel Overview Cabazitaxel Accord is a cancer medicine used to … prostate fluid). Cabazitaxel Accord is used when the cancer has … -
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Human medicine European public assessment report (EPAR): Deferasirox Accord (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,, Revision: 5, Authorised, Last updated: 14/09/2023
Deferasirox Accord Nutritional and Metabolic … deferasirox Overview Deferasirox Accord is a medicine used to treat … from the gut. Deferasirox Accord contains the The substance … -
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 12, Authorised, Last updated: 16/08/2023
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): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 17, Authorised, Last updated: 14/09/2023
Docetaxel Accord Cancer Neoplasms Breast … docetaxel Overview Docetaxel Accord is a cancer medicine used … breast cancer. Docetaxel Accord can be used on its own after … -
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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 … Overview Dexmedetomidine Accord is a medicine used to sedate … sedation). Dexmedetomidine Accord contains the The substance … -
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Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,
, , Revision: 1, Authorised, Last updated: 07/08/2023
Plerixafor Accord Lymphoproliferative Disorders Lymphatic … plerixafor Overview Plerixafor Accord is a medicine used to mobilise … same patient. Plerixafor Accord is used together with the … -
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 29/03/2023
Azacitidine Accord Cancer Neoplasms Bone … azacitidine Overview Azacitidine Accord is used for the treatment … myeloid cells). Azacitidine Accord is used in patients with … -
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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): 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 Overview 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): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 16, Authorised, Last updated: 21/06/2023
Levetiracetam Accord Nervous System Diseases Central … EPAR) for Levetiracetam Accord. It explains how the Committee … of use for Levetiracetam Accord. Expand section Collapse section … -
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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: 5, Authorised, Last updated: 07/07/2023
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: 17, Authorised, Last updated: 14/06/2023
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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Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
Capecitabine Accord Cancer Neoplasms Colorectal … details Name Capecitabine Accord Agency product number EMEA/H/C/002386 … Marketing-authorisation holder Accord Healthcare S.L.U. Revision 16 Date of … -
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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): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 6, Authorised, Last updated: 21/04/2023
Eptifibatide Accord Cardiovascular Diseases Heart … report (EPAR) for Eptifibatide Accord. It explains how the Agency … on how to use Eptifibatide Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 13, Authorised, Last updated: 25/03/2022
Bortezomib Accord Hemostatic Disorders Vascular … Bortezomib Accord is a cancer medicine used … these patients, Bortezomib Accord is used either on its own … -
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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): 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): Sunitinib Accord
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 11/02/2021,, , Revision: 1, Authorised, Last updated: 14/12/2021
Sunitinib Accord Cancer Neoplasms Neoplasms … sunitinib Overview Sunitinib Accord is a medicine used to treat … of these organs. Sunitinib Accord is used in patients with …