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Medicine type Accelerated assessment Remove Accelerated assessment filter Additional monitoring Remove Additional monitoring filter Exceptional circumstances Remove Exceptional circumstances filter Orphan medicine Remove Orphan medicine filter Biosimilar Remove Biosimilar filter Conditional approval Remove Conditional approval filter

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Referrals Remove Referrals filter Withdrawn applications Remove Withdrawn applications filter

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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): Imfinzi (updated)

durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018, , Revision: 18, 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): Fulphila (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018, , Revision: 11, 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): Mylotarg (updated)

gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018, , Revision: 12, 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
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Human medicine European public assessment report (EPAR): Bimzelx (updated)

bimekizumab, Psoriasis
Date of authorisation: 20/08/2021, , Revision: 5, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , Revision: 3, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Cresemba (updated)

isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, , Revision: 17, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Vyvgart (updated)

Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022, , , Revision: 4, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Lunsumio (updated)

mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022, , , , Revision: 2, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Skyrizi (updated)

Risankizumab, Psoriasis; Arthritis, Psoriatic
Date of authorisation: 26/04/2019, , Revision: 18, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Zirabev (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019, , , Revision: 13, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Oyavas (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: 26/03/2021, , , Revision: 6, Authorised, Last updated: 09/11/2023