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204 results

Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Conditional approval Remove Conditional approval filter

Medicine Orphan designations Remove Orphan designations filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter

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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: 22, 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): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 6, Authorised, Last updated: 01/08/2022
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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: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , , Revision: 11, Authorised, Last updated: 28/07/2022
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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: 26, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Libtayo (updated)

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 12, Authorised, Last updated: 28/07/2022
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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: 22, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)

larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019, , , Revision: 6, Authorised, Last updated: 26/07/2022
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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, , , Revision: 21, Authorised, Last updated: 25/07/2022
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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: 26, Authorised, Last updated: 22/07/2022
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Human medicine European public assessment report (EPAR): Zolgensma (updated)

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 6, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Kinpeygo (updated)

budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022, , , , Authorised, Last updated: 18/07/2022
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Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 31, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , , Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo

Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , , Revision: 5, Withdrawn, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Exviera

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , Revision: 24, Authorised, Last updated: 07/07/2022
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Human medicine European public assessment report (EPAR): Harvoni

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sovaldi

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Paxlovid

(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, , Revision: 2, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Caprelsa

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 22, Authorised, Last updated: 30/06/2022