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Medicine
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Human medicine European public assessment report (EPAR): Imvanex (updated)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,
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, Revision: 21, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,
, Revision: 18, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, 
, Revision: 18, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 8, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011, Revision: 32, Authorised, Last updated: 09/08/2022 -
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Human medicine European public assessment report (EPAR): Signifor (updated)
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 14, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Thymanax (updated)
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 24, Authorised, Last updated: 08/08/2022 -
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Human medicine European public assessment report (EPAR): Esbriet (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 27/02/2011, Revision: 31, Authorised, Last updated: 08/08/2022 -
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Human medicine European public assessment report (EPAR): Viagra (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 13/09/1998, Revision: 41, Authorised, Last updated: 08/08/2022 -
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 25, Authorised, Last updated: 08/08/2022
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Human medicine European public assessment report (EPAR): Valdoxan (updated)
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022 -
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 11, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Braftovi (updated)
Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018,, Revision: 10, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Cyramza (updated)
Ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014, Revision: 14, Authorised, Last updated: 04/08/2022 -
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Human medicine European public assessment report (EPAR): Myclausen (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 07/10/2010,
, Revision: 15, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Topotecan Hospira (updated)
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 09/06/2010, Revision: 19, Authorised, Last updated: 04/08/2022 -
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 24, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 7, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma) (updated)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
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Human medicine European public assessment report (EPAR): Rezolsta (updated)
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 14, Authorised, Last updated: 03/08/2022 -
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Human medicine European public assessment report (EPAR): Humira (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 86, Authorised, Last updated: 02/08/2022 -
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Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 27, Authorised, Last updated: 02/08/2022 -
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Human medicine European public assessment report (EPAR): Lonquex (updated)
lipegfilgrastim, Neutropenia
Date of authorisation: 25/07/2013, Revision: 23, Authorised, Last updated: 02/08/2022 -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, Revision: 19, Authorised, Last updated: 02/08/2022 -
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022