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

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

Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021, , Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Sarclisa (updated)

Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020, , Revision: 5, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , , Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Amversio (updated)

betaine, Homocystinuria
Date of authorisation: 05/05/2022, , , Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Xevudy (updated)

Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021, , Revision: 3, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Supemtek (updated)

Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human
Date of authorisation: 16/11/2020, , Revision: 2, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Libtayo (updated)

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 12, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , , Revision: 22, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Ryeqo (updated)

relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021, , Revision: 4, Authorised, Last updated: 27/07/2022
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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, , , Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Wegovy (updated)

semaglutide, Obesity; Overweight
Date of authorisation: 06/01/2022, , Revision: 1, Authorised, Last updated: 26/07/2022
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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: 11, Authorised, Last updated: 26/07/2022
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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: 4, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Orgovyx (updated)

relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022, , Revision: 3, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Bavencio (updated)

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 13, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Fintepla (updated)

Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020, , , Revision: 3, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)

larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019, , , Revision: 6, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Rhokiinsa (updated)

Netarsudil, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 19/11/2019, , Revision: 2, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Cablivi (updated)

Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018, , , Revision: 6, Authorised, Last updated: 26/07/2022
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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: 12, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018, , , Revision: 5, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Keytruda (updated)

Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, , Revision: 47, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)

teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012, , , Revision: 20, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Fotivda (updated)

tivozanib, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017, , Revision: 8, Authorised, Last updated: 25/07/2022