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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter

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Medicine type Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Orphan medicine Remove Orphan medicine filter Additional monitoring Remove Additional monitoring filter

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

brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018, , Revision: 8, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , Revision: 24, Authorised, Last updated: 18/05/2022
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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): 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): 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): 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): Zytiga (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011, , Revision: 24, 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): 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
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Human medicine European public assessment report (EPAR): Apexxnar (updated)

Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022, , Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Rhokiinsa (updated)

Netarsudil, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 19/11/2019, , Revision: 1, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Kevzara (updated)

sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017, , Revision: 8, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Naglazyme (updated)

galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006, , , Revision: 19, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Kengrexal (updated)

cangrelor, Acute Coronary Syndrome; Vascular Surgical Procedures
Date of authorisation: 23/03/2015, , Revision: 13, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Nexavar (updated)

sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006, , Revision: 30, Authorised, Last updated: 10/05/2022