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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): 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): Sivextro (updated)

tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 23/03/2015, Revision: 21, 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): Eucreas (updated)

vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 14/11/2007, Revision: 23, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Memantine Mylan (updated)

memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013, , Revision: 10, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Mimpara (updated)

cinacalcet hydrochloride, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 25, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan (updated)

Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020, , Revision: 4, 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): Deferasirox Mylan (updated)

deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019, , Revision: 9, Authorised, Last updated: 28/03/2023
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Human medicine European public assessment report (EPAR): Opdivo (updated)

nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 52, Authorised, Last updated: 28/03/2023
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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): Briviact (in Italy: Nubriveo) (updated)

Brivaracetam, Epilepsy
Date of authorisation: 13/01/2016, Revision: 20, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Lynparza (updated)

Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 20, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Xromi (updated)

hydroxycarbamide, Anemia, Sickle Cell
Date of authorisation: 01/07/2019, Revision: 6, 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): 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): 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): Azopt (updated)

brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 27, Authorised, Last updated: 24/03/2023