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Human medicine European public assessment report (EPAR): Trazimera (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,
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, Revision: 10, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Oyavas (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: 26/03/2021,, , Revision: 1, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,
, Revision: 13, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 3, Authorised, Last updated: 27/01/2022
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Human medicine European public assessment report (EPAR): Prasugrel Mylan (updated)
prasugrel besilate, Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
Date of authorisation: 15/05/2018,, Revision: 7, Authorised, Last updated: 27/01/2022
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord (updated)
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 1, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma (updated)
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 2, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Revision: 1, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
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, Revision: 31, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 24, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Hukyndra (updated)
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 1, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 6, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 6, Authorised, Last updated: 24/01/2022
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Human medicine European public assessment report (EPAR): Pelmeg (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 7, Authorised, Last updated: 24/01/2022
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Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 3, Authorised, Last updated: 24/01/2022
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord (updated)
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
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Human medicine European public assessment report (EPAR): Repaglinide Accord (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 22/12/2011,, Revision: 7, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 9, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, Revision: 10, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , 
, Revision: 5, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 10, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 12, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 7, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, Revision: 21, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 7, Authorised, Last updated: 19/01/2022