10841 results
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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … medicines are manufactured according to the same quality standards … Erlotinib Accord Erlotinib Accord erlotinib … -
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … Tigecycline Accord: Withdrawal of the marketing … medicines are manufactured according to the same quality standards … -
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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 … Cabazitaxel Accord 20 mg/mL concentrate for … Cabazitaxel Accord Cabazitaxel Accord cabazitaxel cabazitaxel ca … -
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
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 … medicines are manufactured according to the same quality standards … -
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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 … Aripiprazole Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 5, Authorised, Last updated: 19/07/2022
Azacitidine Accord Cancer Neoplasms Bone … Azacitidine Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
Entecavir Accord Infections Communicable … Entecavir Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 12/04/2022
Dexmedetomidine Accord Therapeutics Drug Therapy … Dexmedetomidine Accord … medicines are manufactured according to the same quality standards … -
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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 … Voriconazole Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Pregabalin Accord
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 14, Authorised, Last updated: 21/04/2022
Pregabalin Accord Mental Disorders Nervous … Pregabalin Accord … medicines are manufactured according to the same quality standards … -
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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: 23, Authorised, Last updated: 23/06/2022
Imatinib Accord Neoplasms Cancer Leukemia … Imatinib Accord … medicines are manufactured according to the same quality standards … -
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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 … medicines are manufactured according to the same quality standards … -
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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 … medicines are manufactured according to the same quality standards … -
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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 … Eptifibatide Accord … medicines are manufactured according to the same quality standards … -
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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: 2, Authorised, Last updated: 08/04/2022
Cabazitaxel Accord Prostatic Neoplasms Genital … Cabazitaxel Accord … medicines are manufactured according to the same quality standards … -
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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 … Temozolomide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 5, Authorised, Last updated: 09/02/2022
Posaconazole Accord Infections Bacterial Infections … Posaconazole Accord … medicines are manufactured according to the same quality standards … -
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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 … medicines are manufactured according to the same quality standards … -
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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 … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 9, Authorised, Last updated: 13/01/2022
Lacosamide Accord Nervous System Diseases Central … Lacosamide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 14, Authorised, Last updated: 13/01/2022
Levetiracetam Accord Nervous System Diseases Central … Levetiracetam Accord … medicines are manufactured according to the same quality standards … -
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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 … Repaglinide Accord … medicines are manufactured according to the same quality standards … -
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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 … Palonosetron Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Accord
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,, Revision: 2, Authorised, Last updated: 28/03/2022
Rivaroxaban Accord Cardiovascular Diseases Vascular … Rivaroxaban Accord … medicines are manufactured according to the same quality standards … -
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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 … medicines are manufactured according to the same quality standards …