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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015,
, Revision: 44, Authorised, Last updated: 17/05/2022
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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: 28, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Bimzelx (updated)
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 1, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,
, Revision: 7, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide ratiopharm (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,, Revision: 16, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 16, Authorised, Last updated: 16/05/2022
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 19, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 26/09/2017,, Revision: 15, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, , Revision: 33, Authorised, Last updated: 12/05/2022
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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: 16, Authorised, Last updated: 12/05/2022
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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: 11, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, 
, Revision: 22, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 25, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Revision: 20, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 19, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 13, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Inflectra (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 29, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 15, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Iclusig (updated)
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 23, Authorised, Last updated: 11/05/2022