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Medicine
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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): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,
, Revision: 12, 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): Zabdeno (updated)
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,
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, Revision: 5, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 4, 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): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,, , Authorised, Last updated: 23/11/2023
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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): Epoetin Alfa Hexal (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 24, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Binocrit (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 22, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Obizur (updated)
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 11, Authorised, Last updated: 20/11/2023
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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): 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): Fulphila (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, Revision: 11, 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): Tyruko (updated)
natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023,, , Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Kauliv (updated)
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023,, , Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, 
, , Revision: 3, Authorised, Last updated: 13/11/2023
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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): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 13, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Oyavas (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 6, 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): Zokinvy (updated)
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, , , Revision: 2, 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