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

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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)

Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013, , , Revision: 22, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 28, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Retsevmo (updated)

Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021, , , Revision: 6, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Xerava (updated)

eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018, , Revision: 6, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Evusheld (updated)

tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022, , Revision: 2, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)

pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021, , Revision: 4, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Bylvay (updated)

Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021, , , , Revision: 2, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Tibsovo (updated)

Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023, , , Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)

pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021, , , , Revision: 5, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Lenvima (updated)

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 18, Authorised, Last updated: 11/05/2023
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, COVID-19 virus infection
Date of authorisation: 03/07/2020, , Revision: 18, Authorised, Last updated: 11/05/2023
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Human medicine European public assessment report (EPAR): Ondexxya (updated)

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 14, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Kymriah (updated)

tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018, , Revision: 14, Authorised, Last updated: 10/05/2023
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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: 3, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Padcev (updated)

Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022, , Revision: 1, Authorised, Last updated: 08/05/2023
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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: 17, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Lojuxta (updated)

Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013, , , Revision: 16, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Luxturna (updated)

voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018, , , Revision: 6, Authorised, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): Calquence (updated)

Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020, , Revision: 5, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Rybelsus (updated)

semaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2020, , Revision: 5, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Ozempic (updated)

semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018, , Revision: 10, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Xenpozyme (updated)

Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022, , , Revision: 1, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Tegsedi (updated)

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , Revision: 14, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 16, Authorised, Last updated: 02/05/2023
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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: 2, Authorised, Last updated: 02/05/2023