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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)

dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017, , , , Revision: 14, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Orgovyx (updated)

relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022, , Revision: 5, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , Revision: 18, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Enjaymo (updated)

sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022, , , Revision: 1, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Blenrep (updated)

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 5, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Grasustek (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019, , , Revision: 4, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Tegsedi (updated)

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , Revision: 13, Authorised, Last updated: 31/03/2023
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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: 31/03/2023
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Human medicine European public assessment report (EPAR): Jyseleca (updated)

filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020, , , Revision: 8, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , , Revision: 13, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Cibinqo (updated)

Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021, , , Revision: 3, Authorised, Last updated: 30/03/2023
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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: 25, Authorised, Last updated: 29/03/2023
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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): Tecovirimat SIGA (updated)

Tecovirimat, Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox
Date of authorisation: 06/01/2022, , Revision: 1, 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): Imraldi (updated)

adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017, , Revision: 20, Authorised, Last updated: 24/03/2023
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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): Kanjinti (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018, , Revision: 10, 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