11920 results
Keyword Bortezomib Accord Remove keyword
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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): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 01/03/2022
Bortezomib Hospira Hemostatic Disorders Vascular … assessment report (EPAR) for Bortezomib Hospira. It explains how … practical advice on how to use Bortezomib Hospira. For practical information … -
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 09/09/2021
Bortezomib Sun Hemostatic Disorders Vascular … assessment report (EPAR) for Bortezomib Sun. It explains how the … practical advice on how to use Bortezomib Sun. For practical information … -
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 01/09/2021
Bortezomib Fresenius Kabi Hemostatic … Bortezomib Fresenius Kabi is a medicine … transplant. In these patients, Bortezomib Fresenius Kabi is used in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Velcade, bortezomib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Bortezomib, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder of solution for injection
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XBortezomib Oncology … product specific waiver for bortezomib (Velcade) EMEA-000233-PIP01-08 … Velcade) EMEA-000233-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … -
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Human medicine European public assessment report (EPAR): Velcade
bortezomib, Multiple Myeloma
Date of authorisation: 26/04/2004, Revision: 45, Authorised, Last updated: 04/06/2021bortezomib … Velcade bortezomib bortezomib … -
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Withdrawn application: Velcade
bortezomib, date of withdrawal: 02/07/2012, Post-authorisation, Last updated: 30/08/2012authorisation for Velcade (bortezomib) On 2 July 2012, Janssen-Cilag … contains the active substance bortezomib. It has been authorised in … active substance in Velcade, bortezomib, is a proteasome inhibitor … -
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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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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: 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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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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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Dimethyl fumarate Accord: Pending EC decision … authorisation) Dimethyl fumarate Accord dimethyl fumarate On 15 … product Dimethyl fumarate Accord, intended for the treatment … -
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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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Summary of opinion: Dabigatran Etexilate Accord
dabigatran etexilate, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023Dabigatran Etexilate Accord: Pending EC decision … Dabigatran Etexilate Accord … authorisation) Dabigatran etexilate Accord dabigatran etexilate On … -
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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 … Imatinib 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: 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): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 15, Authorised, Last updated: 24/03/2023
Levetiracetam Accord Nervous System Diseases Central … EPAR) for Levetiracetam Accord. It explains how the The committee … of use for Levetiracetam Accord. What is Levetiracetam Accord and what is it used for … -
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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: 4, Authorised, Last updated: 08/05/2023
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): 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 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: 6, Authorised, Last updated: 25/01/2023
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): Docetaxel Accord
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 16, Authorised, Last updated: 20/03/2023
Docetaxel Accord Cancer Neoplasms Breast … Docetaxel 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: 15, Authorised, Last updated: 09/01/2023
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): 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 … 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: 3, Authorised, Last updated: 16/01/2023
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): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 30/11/2022
Lacosamide Accord Nervous System Diseases Central … Lacosamide Accord … medicines are manufactured according to the same quality standards …