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407 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

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Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)

Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023, , Revision: 1, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)

emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016, , Revision: 8, Authorised, Last updated: 24/11/2023
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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: 9, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)

pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015, , Revision: 17, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Takhzyro (updated)

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , Revision: 12, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)

efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017, , Revision: 16, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tagrisso (updated)

osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016, , Revision: 19, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 21, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)

fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021, , Revision: 5, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)

posaconazole, Mycoses
Date of authorisation: 25/07/2019, , Revision: 6, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)

sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009, , Revision: 17, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Silodosin Recordati (updated)

silodosin, Prostatic Hyperplasia
Date of authorisation: 07/01/2019, , Revision: 2, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)

tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017, , Revision: 8, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Degarelix Accord (updated)

degarelix acetate, Prostatic Neoplasms
Date of authorisation: 29/09/2023, , Authorised, Last updated: 08/11/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Accord

pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016, , Revision: 10, Authorised, Last updated: 27/10/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT

Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 17, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Telmisartan Actavis

Telmisartan, Hypertension
Date of authorisation: 29/09/2010, , Revision: 13, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Thiotepa Riemser

thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021, , Revision: 4, Authorised, Last updated: 23/10/2023
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Human medicine European public assessment report (EPAR): Imatinib Koanaa

imatinib mesilate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma; Gastrointestinal Stromal Tumors
Date of authorisation: 22/09/2021, , Withdrawn, Last updated: 19/10/2023
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Human medicine European public assessment report (EPAR): Lacosamide Adroiq

lacosamide, Epilepsy
Date of authorisation: 31/05/2023, , Revision: 2, Authorised, Last updated: 13/10/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH

pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015, , Revision: 16, Withdrawn, Last updated: 12/10/2023
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Human medicine European public assessment report (EPAR): Spinraza

nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017, , , Revision: 14, Authorised, Last updated: 12/10/2023
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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: 5, Authorised, Last updated: 12/10/2023
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Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 18, Authorised, Last updated: 10/10/2023
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Human medicine European public assessment report (EPAR): Bortezomib Hospira

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 13, Authorised, Last updated: 09/10/2023

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407 results

Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)

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

Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)

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

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)

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

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

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

Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)

Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)

Human medicine European public assessment report (EPAR): Silodosin Recordati (updated)

Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)

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

Human medicine European public assessment report (EPAR): Pemetrexed Accord

Human medicine European public assessment report (EPAR): Actelsar HCT

Human medicine European public assessment report (EPAR): Telmisartan Actavis

Human medicine European public assessment report (EPAR): Thiotepa Riemser

Human medicine European public assessment report (EPAR): Imatinib Koanaa

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

Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH

Human medicine European public assessment report (EPAR): Spinraza

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

Human medicine European public assessment report (EPAR): Cabometyx

Human medicine European public assessment report (EPAR): Bortezomib Hospira