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Medicine 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filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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Human medicine European public assessment report (EPAR): Prevymis (updated)

Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018, , Revision: 14, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Krka (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021, , Revision: 2, Authorised, Last updated: 08/03/2023
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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: 5, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Senshio (updated)

ospemifene, Postmenopause
Date of authorisation: 14/01/2015, , Revision: 13, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi) (updated)

Lusutrombopag, Thrombocytopenia
Date of authorisation: 18/02/2019, , Revision: 8, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Kauliv (updated)

teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023, , , Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008, , Revision: 16, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Tecvayli (updated)

Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022, , , Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)

capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012, , Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)

edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016, , Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Veyvondi (updated)

vonicog alfa, von Willebrand Diseases
Date of authorisation: 31/08/2018, , Revision: 6, Authorised, Last updated: 06/03/2023
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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: 4, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz (updated)

temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010, , Revision: 17, Withdrawn, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Inhixa (updated)

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , Revision: 23, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Mysimba (updated)

bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015, , Revision: 24, Authorised, Last updated: 03/03/2023
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Human medicine European public assessment report (EPAR): Efavirenz Teva (updated)

efavirenz, HIV Infections
Date of authorisation: 09/01/2012, , Revision: 12, Authorised, Last updated: 03/03/2023
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Human medicine European public assessment report (EPAR): Aimovig (updated)

erenumab, Migraine Disorders
Date of authorisation: 26/07/2018, , Revision: 9, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Revlimid (updated)

lenalidomide, Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes
Date of authorisation: 14/06/2007, , Revision: 49, Authorised, Last updated: 02/03/2023
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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: 02/03/2023
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Human medicine European public assessment report (EPAR): Imjudo (updated)

Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 15/12/2022, , Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Scemblix (updated)

asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022, , , Revision: 2, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 25, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020, , Revision: 8, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Spravato (updated)

esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019, , Revision: 7, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Revestive (updated)

teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012, , , Revision: 21, Authorised, Last updated: 01/03/2023