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751 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

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

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 11, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): PreHevbri (updated)

hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022, , Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)

avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020, , , Revision: 4, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Padcev (updated)

Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022, , Authorised, Last updated: 18/05/2022
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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): 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): 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): 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): 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): 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

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751 results

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

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)

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

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

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

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

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

Human medicine European public assessment report (EPAR): SomaKit TOC (updated)

Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

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

Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)

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

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

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

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

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