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Human medicine European public assessment report (EPAR): Foclivia (updated)

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009, , Revision: 13, Authorised, Last updated: 03/10/2023
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Human medicine European public assessment report (EPAR): Docetaxel Kabi (updated)

docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012, , Revision: 15, Authorised, Last updated: 29/09/2023
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Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)

rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020, , Revision: 5, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)

imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013, , Revision: 19, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)

Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020, , Revision: 5, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Myfenax (updated)

mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008, , Revision: 27, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Abiraterone Accord (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021, , Revision: 1, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Olanzapine Teva (updated)

olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007, , Revision: 30, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)

cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012, , , Revision: 13, Authorised, Last updated: 25/09/2023
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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
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 27, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

levetiracetam, Epilepsy
Date of authorisation: 14/12/2011, , Revision: 19, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)

Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017, , , , Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Mepsevii (updated)

vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018, , , , Revision: 7, Authorised, Last updated: 14/09/2023
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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
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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
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)

carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018, , Revision: 8, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Lacosamide Adroiq (updated)

lacosamide, Epilepsy
Date of authorisation: 31/05/2023, , Revision: 1, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)

influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009, , Revision: 8, Withdrawn, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021, , Revision: 4, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)

aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015, , Revision: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)

dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022, , Revision: 4, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Irbesartan Teva (updated)

irbesartan, Hypertension
Date of authorisation: 30/10/2009, , Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)

Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022, , Revision: 3, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Duloxetine Mylan

duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015, , Revision: 18, Authorised, Last updated: 25/08/2023

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434 results

Human medicine European public assessment report (EPAR): Foclivia (updated)

Human medicine European public assessment report (EPAR): Docetaxel Kabi (updated)

Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)

Human medicine European public assessment report (EPAR): Imatinib Teva (updated)

Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)

Human medicine European public assessment report (EPAR): Myfenax (updated)

Human medicine European public assessment report (EPAR): Abiraterone Accord (updated)

Human medicine European public assessment report (EPAR): Olanzapine Teva (updated)

Human medicine European public assessment report (EPAR): Orphacol (updated)

Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)

Human medicine European public assessment report (EPAR): Vyndaqel (updated)

Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)

Human medicine European public assessment report (EPAR): Mepsevii (updated)

Human medicine European public assessment report (EPAR): Docetaxel Accord (updated)

Human medicine European public assessment report (EPAR): Deferasirox Accord (updated)

Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)

Human medicine European public assessment report (EPAR): Lacosamide Adroiq (updated)

Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)

Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)

Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)

Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)

Human medicine European public assessment report (EPAR): Irbesartan Teva (updated)

Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)

Human medicine European public assessment report (EPAR): Duloxetine Mylan