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

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016, , , Revision: 8, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Sogroya (updated)

Somapacitan, Growth
Date of authorisation: 31/03/2021, , , Revision: 1, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Cresemba (updated)

isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, , Revision: 14, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Vaborem (updated)

meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018, , Revision: 6, Authorised, Last updated: 29/07/2022
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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): 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): Vyxeos liposomal (previously known as Vyxeos) (updated)

daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018, , Revision: 7, 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