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1006 results

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reports (EPAR) filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter

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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , Revision: 9, Authorised, Last updated: 01/12/2023
List item

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

Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012, , Revision: 35, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 17, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Kalydeco (updated)

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 38, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Soliris (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 36, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 13, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Vyvgart (updated)

Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022, , , Revision: 5, Authorised, Last updated: 28/11/2023
List item

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): Tecartus (updated)

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020, , , , Revision: 5, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Holoclar (updated)

ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015, , , , Revision: 10, Authorised, Last updated: 24/11/2023
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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
List item

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

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 18, 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
List item

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

tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018, , Revision: 12, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Talvey (updated)

talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023, , , , Revision: 1, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Voxzogo (updated)

Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021, , , Revision: 4, 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
List item

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

pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021, , , Revision: 6, Authorised, Last updated: 21/11/2023
List item

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

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , Revision: 17, Authorised, Last updated: 21/11/2023
List item

Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)

daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018, , Revision: 9, Authorised, Last updated: 20/11/2023
List item

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

recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014, , , Revision: 13, Authorised, Last updated: 20/11/2023
List item

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
List item

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
List item

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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1006 results

Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Voxzogo (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): Gavreto (updated)

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

Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)

Human medicine European public assessment report (EPAR): Vimizim (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)