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Human medicine European public assessment report (EPAR): Ogluo
Glucagon, Diabetes Mellitus
Date of authorisation: 11/02/2021, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Yuflyma
adalimumab, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Arthritis, Juvenile Rheumatoid, Hidradenitis Suppurativa, Uveitis
Date of authorisation: 11/02/2021,
, Authorised, Last updated: 26/02/2021
fight off infections and cancer, and there have been some … serious infections and blood cancers in patients using adalimumab … fight off infections and cancer, and there have been some … -
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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): Lenalidomide Krka
lenalidomide hydrochloride monohydrate, Multiple Myeloma, Lymphoma, Follicular
Date of authorisation: 11/02/2021,
, Authorised, Last updated: 18/02/2021
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): Lenalidomide Krka d.d. Novo mesto
lenalidomide hydrochloride monohydrate, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Follicular, Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,, Authorised, Last updated: 18/02/2021
the treatment of certain cancers and serious conditions affecting … the treatment of certain cancers and serious conditions affecting … In multiple myeloma, a cancer of a type of white blood … -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d.
lenalidomide hydrochloride hydrate, Multiple Myeloma, Lymphoma, Follicular, Myelodysplastic Syndromes
Date of authorisation: 11/02/2021,, Authorised, Last updated: 18/02/2021
the treatment of certain cancers and serious conditions affecting … the treatment of certain cancers and serious conditions affecting … In multiple myeloma, a cancer of a type of white blood … -
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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: 05/02/2021
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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
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Authorised, Last updated: 07/01/2021
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,, 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: 25/02/2021
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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): 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 …