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734 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Summaries of opinion Remove Summaries of opinion filter Referrals Remove Referrals filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

Tislelizumab, Esophageal Squamous Cell Carcinoma
Date of authorisation: 15/09/2023, , , Authorised, Last updated: 02/10/2023
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Human medicine European public assessment report (EPAR): Tyenne (updated)

tocilizumab, Arthritis, Rheumatoid; Cytokine Release Syndrome; Arthritis, Juvenile Rheumatoid; COVID-19 virus infection; Giant Cell Arteritis
Date of authorisation: 15/09/2023, , Authorised, Last updated: 02/10/2023
List item

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): SomaKit TOC (updated)

edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016, , Revision: 15, Authorised, Last updated: 29/09/2023
List item

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

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , Revision: 11, Authorised, Last updated: 28/09/2023
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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
List item

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): Tyruko (updated)

natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023, , , Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 3, Authorised, Last updated: 27/09/2023
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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): Trepulmix (updated)

Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020, , Revision: 4, Authorised, Last updated: 27/09/2023
List item

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
List item

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
List item

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

Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023, , Revision: 2, Authorised, Last updated: 25/09/2023
List item

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): Amglidia (updated)

glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018, , Revision: 7, 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
List item

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
List item

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
List item

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

asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022, , , Revision: 3, Authorised, Last updated: 22/09/2023
List item

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
List item

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

lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017, , Revision: 10, Authorised, Last updated: 22/09/2023
List item

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

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , Revision: 9, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Talvey (updated)

talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023, , , , Authorised, Last updated: 21/09/2023
List item

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

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018, , Revision: 20, Authorised, Last updated: 20/09/2023

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734 results

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

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

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

Human medicine European public assessment report (EPAR): SomaKit TOC (updated)

Human medicine European public assessment report (EPAR): Hepcludex (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): Tyruko (updated)

Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

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

Human medicine European public assessment report (EPAR): Trepulmix (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): Hyftor (updated)

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

Human medicine European public assessment report (EPAR): Amglidia (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): Scemblix (updated)

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

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

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

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

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