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628 results

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

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

Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014, , , Revision: 15, Withdrawn, Last updated: 04/10/2023
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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
List item

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): 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): Trepulmix (updated)

Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020, , Revision: 4, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Sovaldi (updated)

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 28, Authorised, Last updated: 27/09/2023
List item

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

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 28, Authorised, Last updated: 27/09/2023
List item

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

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 22, Authorised, Last updated: 27/09/2023
List item

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

Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023, , , Authorised, Last updated: 26/09/2023
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
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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): Evrysdi (updated)

Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021, , Revision: 5, 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): 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): 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): Strimvelis (updated)

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016, , , Revision: 9, Authorised, Last updated: 19/09/2023
List item

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
List item

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): 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
List item

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

valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022, , , , Revision: 3, Authorised, Last updated: 12/09/2023
List item

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

pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021, , , , Revision: 6, Authorised, Last updated: 12/09/2023
List item

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

Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017, , Revision: 9, Authorised, Last updated: 11/09/2023

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628 results

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

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

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

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

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

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

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

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

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

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

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

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

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