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Medicine Direct healthcare professional communication Remove Direct healthcare professional communication filter Summaries of opinion Remove Summaries of opinion filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter

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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): 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): Vanflyta (updated)

Quizartinib dihydrochloride, Leukemia, Myeloid
Date of authorisation: 06/11/2023, , Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Exjade (updated)

deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006, , Revision: 52, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Esperoct (updated)

Turoctocog alfa pegol, Hemophilia A
Date of authorisation: 20/06/2019, , Revision: 6, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tepmetko (updated)

Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2022, , Revision: 2, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Obizur (updated)

susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015, , , Revision: 11, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Vimizim (updated)

recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014, , , Revision: 13, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tagrisso (updated)

osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016, , Revision: 19, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 21, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Ajovy (updated)

fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019, , Revision: 10, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Jaypirca (updated)

pirtobrutinib, Lymphoma, Mantle-Cell
Date of authorisation: 30/10/2023, , , Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Leqvio (updated)

inclisiran, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 09/12/2020, , Revision: 5, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Wakix (updated)

pitolisant, Narcolepsy
Date of authorisation: 31/03/2016, , , Revision: 15, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)

Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014, , , Revision: 16, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tyruko (updated)

natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023, , , Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Kauliv (updated)

teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023, , , Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Lumykras (updated)

sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022, , , Revision: 2, Authorised, Last updated: 20/11/2023
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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: 46, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)

artesunate, Malaria
Date of authorisation: 22/11/2021, , , Revision: 4, Authorised, Last updated: 20/11/2023