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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

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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: 41, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Symkevi (updated)

tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018, , , Revision: 11, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Giapreza (updated)

Angiotensin II acetate, Hypotension; Shock
Date of authorisation: 23/08/2019, , Revision: 3, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Opsumit (updated)

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 22, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)

levetiracetam, Epilepsy
Date of authorisation: 03/10/2011, , Revision: 15, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Bavencio (updated)

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 15, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Zokinvy (updated)

Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022, , , , Revision: 1, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Enspryng (updated)

satralizumab, Neuromyelitis Optica
Date of authorisation: 24/06/2021, , Revision: 2, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Miglustat Dipharma (updated)

miglustat, Gaucher Disease
Date of authorisation: 18/02/2019, , Revision: 5, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Brukinsa (updated)

zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021, , Revision: 5, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Truvelog Mix 30 (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022, , , Revision: 1, Authorised, Last updated: 23/03/2023
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Human medicine European public assessment report (EPAR): Terrosa (updated)

teriparatide, Osteoporosis
Date of authorisation: 04/01/2017, , , Revision: 6, Authorised, Last updated: 23/03/2023
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Human medicine European public assessment report (EPAR): Upstaza (updated)

Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022, , , , Revision: 3, Authorised, Last updated: 23/03/2023
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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: 2, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Polivy (updated)

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 5, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Zynlonta (updated)

loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022, , , Revision: 1, Authorised, Last updated: 22/03/2023
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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: 16, Authorised, Last updated: 22/03/2023
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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, , Revision: 1, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 20, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Ultomiris (updated)

ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019, , Revision: 10, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Imcivree (updated)

Setmelanotide, Obesity
Date of authorisation: 16/07/2021, , , Revision: 7, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)

lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011, , Revision: 16, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Vihuma (updated)

simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017, , Revision: 8, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Beyfortus (updated)

nirsevimab,
Date of authorisation: 31/10/2022, , Revision: 1, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Inrebic (updated)

fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021, , , Revision: 4, Authorised, Last updated: 21/03/2023