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Medicine type Accelerated assessment Remove Accelerated assessment filter Additional monitoring Remove Additional monitoring filter Biosimilar Remove Biosimilar filter Orphan medicine Remove Orphan medicine filter

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designations filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter

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

relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022, , Revision: 8, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Truxima (updated)

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017, , Revision: 20, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Ruxience (updated)

rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020, , , Revision: 11, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Vyvgart (updated)

Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022, , , Revision: 5, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Zessly (updated)

infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018, , Revision: 12, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Tecartus (updated)

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020, , , , Revision: 5, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Orserdu (updated)

elacestrant, Breast Neoplasms
Date of authorisation: 15/09/2023, , Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Pluvicto (updated)

lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022, , Revision: 4, Authorised, Last updated: 27/11/2023
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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, , Revision: 6, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Holoclar (updated)

ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015, , , , Revision: 10, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Zabdeno (updated)

Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020, , , Revision: 5, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Mvabea (updated)

Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020, , , Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 18, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Symkevi (updated)

tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018, , Revision: 12, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Talvey (updated)

talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023, , , , Revision: 1, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Voxzogo (updated)

Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021, , , Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Herwenda (updated)

trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023, , , Authorised, Last updated: 23/11/2023
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Human medicine European public assessment report (EPAR): Takhzyro (updated)

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , Revision: 12, Authorised, Last updated: 22/11/2023
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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: 41, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Gavreto (updated)

pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021, , , Revision: 6, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal (updated)

epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007, , Revision: 24, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Binocrit (updated)

epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007, , Revision: 22, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Fetcroja (updated)

cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020, , Revision: 7, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Respreeza (updated)

Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases
Date of authorisation: 20/08/2015, , Revision: 12, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , Revision: 17, Authorised, Last updated: 21/11/2023