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Human medicine European public assessment report (EPAR): Pepaxti
Melphalan flufenamide hydrochloride, Multiple Myeloma
Date of authorisation: 17/08/2022, Revision: 1, Authorised, Last updated: 19/12/2022with multiple myeloma (a cancer of the bone marrow) when the cancer has not responded to previous … transplantation to when the cancer comes back is at least three … this medicine, is a type of cancer medicine known as an alkylating … -
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Human medicine European public assessment report (EPAR): Zolsketil pegylated liposomal
doxorubicin hydrochloride, liposomal, Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
Date of authorisation: 31/05/2022, Authorised, Last updated: 20/06/2022treat the following types of cancer in adults: • breast cancer that has spread to other … disease; • advanced ovarian cancer in women whose previous treatment … including a platinum-based cancer medicine has stopped working … -
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Human medicine European public assessment report (EPAR): Celdoxome pegylated liposomal
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi
Date of authorisation: 15/09/2022, Authorised, Last updated: 31/01/2023treat the following types of cancer in adults: metastatic breast cancer in patients at risk of heart … ‘Metastatic’ means the cancer has spread to other parts … disease; advanced ovarian cancer in women whose previous treatment … -
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Human medicine European public assessment report (EPAR): Vyvgart
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,
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, Revision: 2, Authorised, Last updated: 22/11/2022
System Nervous System Neoplasms Cancer Neoplasms Paraneoplastic … -
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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: 2, Authorised, Last updated: 22/03/2023
Neoplasms Digestive System Neoplasms Cancer Neoplasms Breast Diseases Skin … bevacizumab Overview Vegzelma is a cancer medicine used to treat adults … with the following types of cancer, in combination with other cancer medicines cancer of the colon (large intestine … -
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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
Conditions, Signs and Symptoms Cancer Neoplasms Leukemia, Myelogenous … asciminib Overview Scemblix is a cancer medicine. It is used to treat … myeloid leukaemia (CML), a cancer of the white blood cells … -
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , 
, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Authorised, Last updated: 20/06/2022Diseases Male Urogenital Diseases Cancer Neoplasms Prostatic Neoplas … treatment of advanced prostate cancer that is ‘hormone-dependent’ … hormone-dependent prostate cancer and high-risk localised prostate … -
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Human medicine European public assessment report (EPAR): Sondelbay
teriparatide, Osteoporosis
Date of authorisation: 24/03/2022,, , Authorised, Last updated: 16/06/2022
as Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … -
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Direct healthcare professional communication (DHPC): Imlygic (talimogene laherparepvec): Special considerations to minimize the potential occurrence of adverse events in HSV-1 seronegative patients receiving vials from affected lots: Injections from Imlygic 106 PFU/mL vials from the affected lot numbers ...
Active substance: talimogene laherparepvec, DHPC type: Adverse event, Quality defect, Last updated: 16/06/2022experienced in the treatment of cancer, pharmacists, hospital pharmacists … -
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Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 30/05/2022adult patients with breast cancer, melanoma, or localised squamous … -
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Human medicine European public assessment report (EPAR): Xenpozyme
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): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , 
, Revision: 3, Authorised, Last updated: 23/03/2023
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Human medicine European public assessment report (EPAR): Sugammadex Fresenius Kabi
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/07/2022,
, Authorised, Last updated: 21/07/2022
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Direct healthcare professional communication (DHPC): Rucaparib (Rubraca® ): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care
Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Last updated: 06/05/2022tube, or primary peritoneal cancer, who have been treated with … tube, or primary peritoneal cancer who are in response (complete … tube, or primary peritoneal cancer, who have 2 been treated … -
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Human medicine European public assessment report (EPAR): Padcev
Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022,, Authorised, Last updated: 15/12/2022
Padcev Cancer Neoplasms, Glandular and … Padcev is a cancer medicine for treating adults … treating adults with urothelial cancer (a cancer of the bladder and urinary … -
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Human medicine European public assessment report (EPAR): Tepmetko
Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2022,, Authorised, Last updated: 05/05/2022
Neoplasms Thoracic Neoplasms Neoplasms Cancer Respiratory Tract Diseases Lung … Tepmetko is a cancer medicine that is used to … with non-small cell lung cancer (NSCLC) when the cancer is advanced and its cells … -
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Human medicine European public assessment report (EPAR): Quviviq (updated)
daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022,, Revision: 4, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Kimmtrak
tebentafusp, Uveal Neoplasms
Date of authorisation: 01/04/2022,, , Authorised, Last updated: 22/04/2022
adults with a type of eye cancer called ‘uveal melanoma’ … experienced in the use of cancer medicines and the treatment … surface of uveal melanoma cancer cells and CD3 on the surface … -
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Human medicine European public assessment report (EPAR): Tabrecta
capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/06/2022,, Revision: 1, Authorised, Last updated: 25/01/2023
Neoplasms Thoracic Neoplasms Cancer Neoplasms Lung Diseases Respiratory … adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the cancer is advanced and its cells … adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the cancer is advanced and its cells … -
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Authorised, Last updated: 23/06/2022
Non-Hodgkin Lymphoma Neoplasms Cancer Lymphoproliferative Disorders Lymphatic … Lunsumio is a cancer medicine used to treat adults … is qualified in the use of cancer medicines, in a location … -
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Revision: 1, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Evusheld
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 1, Authorised, Last updated: 16/11/2022
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 1, Authorised, Last updated: 17/01/2023
kti Neoplasms, Plasma Cell Cancer Hemostatic Disorders Vascular … with multiple myeloma (a cancer of the bone marrow) when the cancer has come back (relapsed … was effective at clearing cancer cells in patients with multiple … -
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Human medicine European public assessment report (EPAR): Amifampridine SERB
amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Date of authorisation: 19/05/2022,, Authorised, Last updated: 24/05/2022
Diseases of the Nervous System Cancer Neoplasms … Diseases of the Nervous System Cancer Neoplasms Anatomical therapeutic …