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Human medicine European public assessment report (EPAR): Ciambra (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 02/12/2015,, Revision: 6, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 11, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Exviera (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Grasustek (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,,
, Revision: 3, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 33, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Pemetrexed medac (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 18, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Myclausen (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 07/10/2010,, Revision: 15, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma) (updated)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 4, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Yuflyma (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021,, Revision: 8, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
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, Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Amversio (updated)
betaine, Homocystinuria
Date of authorisation: 05/05/2022,,
, Authorised, Last updated: 28/07/2022
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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: 2, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 7, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Grepid (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 25, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,,
, Revision: 11, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Granpidam (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 7, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017,, Revision: 13, Authorised, Last updated: 26/07/2022