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

alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017, , Revision: 14, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Kesimpta (updated)

ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021, , Revision: 6, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Glivec (updated)

imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001, , Revision: 45, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Nyvepria (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020, , , Revision: 5, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Tukysa (updated)

Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021, , Revision: 4, Authorised, Last updated: 29/03/2023
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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: 8, Authorised, Last updated: 27/03/2023
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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: 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): 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): 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