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Human medicine European public assessment report (EPAR): Onbevzi
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: 11/01/2021,
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, Authorised, Last updated: 05/03/2021
bevacizumab Overview Onbevzi 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): Inrebic
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis
Date of authorisation: 08/02/2021,, 
, Authorised, Last updated: 03/03/2021
myelofibrosis (a rare form of blood cancer) who have enlarged spleen … experienced in the use of cancer medicines. Inrebic is available … myelofibrosis (a rare form of blood cancer) who have enlarged spleen … -
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Human medicine European public assessment report (EPAR): Heplisav B
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021,, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Tukysa
Tucatinib, Breast Neoplasms, Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Authorised, Last updated: 18/02/2021
tucatinib Overview Tukysa is a cancer medicine that is used to … that is used to treat breast cancer that is locally advanced … HER2-positive. This means the cancer cells produce a protein on … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine AstraZeneca
Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), COVID-19 virus infection
Date of authorisation: 29/01/2021,, 
, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Rukobia
fostemsavir trometamol, HIV Infections
Date of authorisation: 04/02/2021,, Authorised, Last updated: 12/02/2021
carbamazepine and phenytoin, cancer medicines mitotane and enzalutamide … carbamazepine and phenytoin, cancer medicines mitotane and enzalutamide … -
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Authorised, Last updated: 08/02/2021
medicine used to treat breast cancer that is metastatic (has spread … can only be used when the cancer has been shown to ‘overexpress … HER2’: this means that the cancer produces a protein called … -
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Human medicine European public assessment report (EPAR): Tecartus
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Authorised, Last updated: 25/01/2021
Tecartus is a cancer medicine used to treat adults … with mantle cell lymphoma (a cancer of B cells, a type of white … cell). It is used when the cancer has come back after two or … -
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Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , 
, Authorised, Last updated: 25/01/2021
BPDCN), a type of blood cancer which can affect many organs … experienced in the use of cancer medicines, in a setting where … patients being treated for blood cancer. Around one hour before each … -
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Human medicine European public assessment report (EPAR): Xofluza
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,, Authorised, Last updated: 22/01/2021
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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,, , Authorised, Last updated: 04/03/2021
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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): 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): Vocabria
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Authorised, Last updated: 05/01/2021
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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: 3, Authorised, Last updated: 04/03/2021
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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,, , Authorised, Last updated: 22/12/2020
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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): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Authorised, Last updated: 23/11/2020
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): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Authorised, Last updated: 11/11/2020
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
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): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 1, Authorised, Last updated: 06/11/2020
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: 1, Authorised, Last updated: 29/01/2021
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 … Rozlytrek is a cancer medicine. It can be used … of age with solid tumours (cancer growths) that have a genetic …