9378 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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … medicines are manufactured according to the same quality standards … Erlotinib Accord Erlotinib Accord erlotinib … -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020Sunitinib Accord: Pending EC decision … medicines are manufactured according to the same quality standards … authorisation) Sunitinib Accord sunitinib On 10 December … -
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Summary of opinion: Abiraterone Accord
abiraterone, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021Abiraterone Accord: Pending EC decision … authorisation) Abiraterone Accord abiraterone On 25 February … medicinal product Abiraterone Accord, intended for the treatment … -
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … application for Tigecycline Accord (tigecycline) On 12 September … On 12 September 2017, Accord Healthcare Limited officially … -
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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): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 28/08/2015,
, Revision: 9, Authorised, Last updated: 24/02/2021
Pregabalin Accord Anxiety Disorders Epilepsy … 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): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
Lenalidomide Accord Multiple Myeloma … Lenalidomide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
Palonosetron Accord Vomiting Nausea Cancer … Palonosetron Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 12, Authorised, Last updated: 10/02/2021
Levetiracetam Accord Epilepsy … Levetiracetam 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: 8, Authorised, Last updated: 02/02/2021
Bortezomib Accord Multiple Myeloma … Bortezomib Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Entecavir Accord
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 3, Authorised, Last updated: 29/01/2021
Entecavir Accord Hepatitis B, Chronic … Entecavir 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: 1, Authorised, Last updated: 24/11/2020
Posaconazole Accord Mycoses … Posaconazole 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: 3, Authorised, Last updated: 21/10/2020
Eptifibatide Accord Myocardial Infarction … Eptifibatide 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: 11, Authorised, Last updated: 21/10/2020
Aripiprazole Accord Schizophrenia Bipolar Disor … Aripiprazole 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: 6, Authorised, Last updated: 30/09/2020
Repaglinide Accord Diabetes Mellitus, Type 2 … Repaglinide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Docetaxel Accord
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Accord Head and Neck Neoplasms Carcinoma … Docetaxel 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: 5, Authorised, Last updated: 22/07/2020
Lacosamide Accord Epilepsy … Lacosamide Accord … for the public Lacosamide Accord lacosamide This is a summary … -
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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: 16, Authorised, Last updated: 11/09/2020
Imatinib Accord Precursor Cell Lymphoblastic … Imatinib 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: 1, Authorised, Last updated: 21/07/2020
Dexmedetomidine Accord Premedication … 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: 12, Authorised, Last updated: 22/07/2020
Voriconazole Accord Aspergillosis Candidiasis … Voriconazole 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: 19, Authorised, Last updated: 15/07/2020
Temozolomide Accord Glioma Glioblastoma … Temozolomide Accord … medicines are manufactured according to the same quality standards … -
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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: 12, Authorised, Last updated: 03/08/2020
Capecitabine Accord Colonic Neoplasms Breast … Capecitabine 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,, Authorised, Last updated: 02/10/2020
Fampridine Accord Multiple Sclerosis … Fampridine 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,
, , Authorised, Last updated: 28/10/2020
Cabazitaxel Accord Prostatic Neoplasms, Castrat … Cabazitaxel 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,, Authorised, Last updated: 04/03/2020
Deferasirox Accord Iron Overload beta-Thalasse … Deferasirox Accord … medicines are manufactured according to the same quality standards …