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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
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, Revision: 1, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): Qutavina
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,
, Withdrawn, Last updated: 18/01/2021
Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … -
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Human medicine European public assessment report (EPAR): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Authorised, Last updated: 13/01/2021
Phesgo is a cancer medicine for treating adults … ‘HER2-positive’ breast cancer (where a protein called HER2 … called HER2 is found on the cancer cells). It is used in combination … -
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, 
, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,
, Revision: 1, Authorised, Last updated: 31/03/2021
the treatment of certain cancers affecting blood cells, namely … the treatment of certain cancers affecting blood cells, namely … In multiple myeloma, a cancer of a type of white blood … -
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Human medicine European public assessment report (EPAR): Livogiva
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, , Revision: 1, Authorised, Last updated: 07/01/2021
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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Human medicine European public assessment report (EPAR): Trixeo Aerosphere
formoterol fumarate dihydrate, glycopyrronium bromide, budesonide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 09/12/2020, Authorised, Last updated: 05/01/2021 -
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Human medicine European public assessment report (EPAR): Vocabria
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 1, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 5, Authorised, Last updated: 16/04/2021
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Human medicine European public assessment report (EPAR): Libmeldy
autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 1, Authorised, Last updated: 09/03/2021
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Human medicine European public assessment report (EPAR): Turalio
Pexidartinib, Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular
Date of refusal: 28/10/2020,, Refused, Last updated: 18/12/2020
giant cell tumour is a non-cancerous condition in which the tissue … -
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Human medicine European public assessment report (EPAR): Exparel liposomal
bupivacaine, Acute Pain
Date of authorisation: 16/11/2020, Authorised, Last updated: 10/12/2020 -
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Human medicine European public assessment report (EPAR): Phelinun
melphalan hydrochloride, Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Neuroblastoma, Ovarian Neoplasms, Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/11/2020, Authorised, Last updated: 25/11/2020Phelinun is a cancer medicine for treating patients … for treating patients with: cancers of the bone marrow (which … non-Hodgkin lymphomas, which are cancers that affect white blood cells … -
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Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 1, Authorised, Last updated: 23/03/2021
vepria is a medicine used in cancer patients to help with neutropenia … is a common side effect of cancer chemotherapy and can leave … in patients with the blood cancer chronic myeloid leukaemia … -
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 1, Authorised, Last updated: 20/11/2020
myeloid leukaemia (AML, a cancer affecting white blood cells … myelomonocytic leukaemia (a cancer affecting white blood cells … experienced in the use of cancer medicines. Before receiving … -
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Human medicine European public assessment report (EPAR): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Authorised, Last updated: 11/11/2020
acalabrutinib Overview Calquence is a cancer medicine used to treat adults … leukaemia (CLL), a blood cancer affecting B cells (a type … or combined with another cancer medicine, obinutuzumab. Calquence … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, , Authorised, Last updated: 28/10/2020
Cabazitaxel Accord is a cancer medicine used to treat men … castration-resistant prostate cancer. This is a cancer that affects the prostate … Cabazitaxel Accord is used when the cancer has spread to other parts … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 1, Authorised, Last updated: 16/11/2020
Overview Equidacent is a cancer medicine that is used to … adults with the following cancers: cancer of the colon (large bowel … parts of the body; breast cancer that has spread to other … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Authorised, Last updated: 01/10/2020
a rare form of leukaemia (cancer of the white blood cells … treatment with a retinoid and cancer medicines, or when their … -
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Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 1, Authorised, Last updated: 06/11/2020
avapritinib Overview Ayvakyt is a cancer medicine used to treat gastrointestinal … stromal tumour (GIST), a cancer of the stomach and bowel … Ayvakyt is used when the cancer cells have a D842V mutation … -
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 2, Authorised, Last updated: 17/03/2021
Blenrep is a cancer medicine used to treat multiple … treat multiple myeloma (a cancer of the bone marrow). It is … monoclonal antibody (types of cancer medicines), and whose … -
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Authorised, Last updated: 27/10/2020
Rozlytrek Cancer Carcinoma, Non-Small-Cell … entrectinib Overview Rozlytrek is a cancer medicine. It can be used … of age with solid tumours (cancer growths) that have a genetic … -
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Human medicine European public assessment report (EPAR): Aybintio (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: 19/08/2020,, , Revision: 2, Authorised, Last updated: 06/04/2021
bevacizumab Overview Aybintio is a cancer medicine that is used to … adults with the following cancers: cancer of the colon (large bowel … parts of the body; breast cancer that has spread to other … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Cosmo
methylthioninium chloride, Colorectal Neoplasms, Colonoscopy
Date of authorisation: 19/08/2020, Authorised, Last updated: 26/08/2020linked to increased risk of cancer) or carcinoma (a type of cancer) during colonoscopy. At least … in the risk of colorectal cancer if removed. The safety profile … -
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 2, Authorised, Last updated: 17/03/2021