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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

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

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

talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023, , , , Authorised, Last updated: 21/09/2023
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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: 30, Authorised, Last updated: 21/09/2023
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)

pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021, , Revision: 4, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Strimvelis (updated)

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016, , , Revision: 9, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Revlimid (updated)

lenalidomide, Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes
Date of authorisation: 14/06/2007, , Revision: 50, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Veyvondi (updated)

vonicog alfa, von Willebrand Diseases
Date of authorisation: 31/08/2018, , Revision: 8, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Litfulo (updated)

ritlecitinib tosilate, Alopecia Areata
Date of authorisation: 15/09/2023, , Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)

Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017, , , , Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Jinarc (updated)

Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015, , Revision: 20, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris) (updated)

macimorelin acetate, Diagnostic Techniques, Endocrine
Date of authorisation: 11/01/2019, , Revision: 3, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Ranivisio (updated)

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022, , , Revision: 3, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo (updated)

Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023, , , Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Mepsevii (updated)

vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018, , , , Revision: 7, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

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: 40, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Neparvis (updated)

sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016, , Revision: 18, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Xevudy (updated)

Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021, , Revision: 9, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 10, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)

Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013, , Revision: 24, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Mektovi (updated)

binimetinib, Melanoma
Date of authorisation: 20/09/2018, , Revision: 7, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Roctavian (updated)

valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022, , , , Revision: 3, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Evrysdi (updated)

Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021, , Revision: 4, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)

pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021, , , , Revision: 6, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Vegzelma (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022, , , Revision: 4, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Ledaga (updated)

Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017, , Revision: 9, Authorised, Last updated: 11/09/2023
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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: 44, Authorised, Last updated: 11/09/2023