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Medicine
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Human medicine European public assessment report (EPAR): Filsuvez (updated)
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,
, Revision: 1, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Biktarvy (updated)
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, Revision: 15, Authorised, Last updated: 23/01/2023 -
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 15, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,
, Revision: 1, Authorised, Last updated: 20/01/2023
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Human medicine European public assessment report (EPAR): Xofluza (updated)
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,
, Revision: 4, Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter (updated)
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Xarelto (updated)
rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 30/09/2008, Revision: 39, Authorised, Last updated: 18/01/2023 -
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Human medicine European public assessment report (EPAR): Amgevita (updated)
adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Stelara (updated)
Ustekinumab, Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative
Date of authorisation: 15/01/2009, Revision: 42, Authorised, Last updated: 18/01/2023 -
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,
, Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Sarclisa (updated)
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Revision: 6, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis) (updated)
pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016, Revision: 12, Authorised, Last updated: 18/01/2023 -
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Human medicine European public assessment report (EPAR): Lysodren (updated)
Mitotane, Adrenal Cortex Neoplasms
Date of authorisation: 28/04/2004, Revision: 18, Authorised, Last updated: 18/01/2023 -
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Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 15, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 29, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Avonex (updated)
interferon beta-1a, Multiple Sclerosis
Date of authorisation: 13/03/1997, Revision: 36, Authorised, Last updated: 18/01/2023 -
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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,, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 26/09/2017, Revision: 20, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Vaxelis (updated)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
Date of authorisation: 15/02/2016, Revision: 13, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): Instanyl (updated)
Fentanyl citrate, Pain; Cancer
Date of authorisation: 20/07/2009, Revision: 35, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 7, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Cotellic (updated)
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 13, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 31, Authorised, Last updated: 17/01/2023