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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,
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, Revision: 7, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 1, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 10, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 9, Authorised, Last updated: 19/01/2022
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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: 23, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 11, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s. (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 10, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 11, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V. (updated)
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 18, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Libmyris (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,, Authorised, Last updated: 18/01/2022
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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: 16/11/2021,, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Accord (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 8, Authorised, Last updated: 17/01/2022
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 12, Authorised, Last updated: 17/01/2022
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Human medicine European public assessment report (EPAR): Sitagliptin SUN (updated)
sitagliptin fumarate, Diabetes Mellitus, Type 2
Date of authorisation: 09/12/2021,, Authorised, Last updated: 17/01/2022
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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: 11, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, , Revision: 14, Authorised, Last updated: 14/01/2022
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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: 14/01/2022
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,, Revision: 13, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane) (updated)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 9, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Iasibon (updated)
ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Date of authorisation: 21/01/2011,, Revision: 10, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Tolura (updated)
telmisartan, Hypertension
Date of authorisation: 04/06/2010,, Revision: 10, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 14, Authorised, Last updated: 13/01/2022