4914 results
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Human medicine European public assessment report (EPAR): Zomarist
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 23, Authorised, Last updated: 20/03/2023who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … -
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 16, Authorised, Last updated: 30/05/2023
the EU for Ratiograstim to ratiopharm GmbH on 15 September 2008 … -
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Human medicine European public assessment report (EPAR): Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023been seen including lactic acidosis (excess lactic acid in the … been seen including lactic acidosis (excess lactic acid in the … -
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Human medicine European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 25, Authorised, Last updated: 09/11/2022who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … -
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Human medicine European public assessment report (EPAR): Synjardy
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015, Revision: 24, Authorised, Last updated: 25/05/2022patients with: metabolic acidosis (when the body produces more … patients with: • metabolic acidosis (when the body produces more … -
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Human medicine European public assessment report (EPAR): Competact
pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 28/07/2006, Revision: 20, Authorised, Last updated: 20/07/2021own in most cases. Lactic acidosis (a build-up of lactic acid … own in most cases. Lactic acidosis (a build-up of lactic acid … -
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Press release: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
Last updated: 14/10/2016W.L. et al., 'Risk of lactic acidosis or elevated lactate concentrations … al., 'Incidence of lactic acidosis in patients with type 2 diabetes … fatal and nonfatal lactic acidosis with metformin use in type … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021treatment of distal renal tubular acidosis … treatment of distal renal tubular acidosis On 20 June 2017, orphan … treatment of distal renal tubular acidosis. What is distal renal tubular … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,
, Revision: 2, Withdrawn, Last updated: 08/08/2016
acid monohydratezoledronic acidOsteoporosisOsteitis DeformansM05BA08 This is … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 10/08/2015, Positive, Last updated: 27/03/2023encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Orphan designation: Vatiquinone for: Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes
Date of designation: 24/02/2022, Positive, Last updated: 28/04/2022encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020encephalomyopathy, lactic acidosis and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Eporatio
epoetin theta, Kidney Failure, Chronic; Anemia; Cancer
Date of authorisation: 29/10/2009, Revision: 12, Authorised, Last updated: 11/01/2022European Union for Eporatio to ratiopharm GmbH on 29 October 2009 … European Union for Eporatio to ratiopharm GmbH on 29 October 2009 … -
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Orphan designation: 2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 12/12/2017, Positive, Last updated: 03/02/2021encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
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Human medicine European public assessment report (EPAR): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 19, Authorised, Last updated: 30/05/2023any form of acute metabolic acidosis (build up of acid in the … called ketones) or lactic acidosis (build-up of lactic acid … increase the risk of lactic acidosis (see section 4.4) should … -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 21, Authorised, Last updated: 30/05/2023any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … -
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
PDF/727.6 KB) (PDF/727.6 KB) Italian (PDF/662.83 KB) (PDF/662.83 … -
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National expert: Constanze Freiler, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 40.23 KB | PDF
- Curriculum Vitae - 26.43 KB | PDF
Switzerland 3. Employer: TEVA ratiopharm, Vienna • Start date: 042013 • … indication Past 01-04- 2013 01-08- 2018 TEVA ratiopharm null Pharmacovigilance Manager … -
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Human medicine European public assessment report (EPAR): Azarga
brinzolamide, timolol maleate, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 25/11/2008, Revision: 16, Authorised, Last updated: 11/10/2022airways); have hyperchloraemic acidosis (excess acid in the blood … • have hyperchloraemic acidosis (excess acid in the blood … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 19, Authorised, Last updated: 21/04/2023
PDF/90.46 KB) (PDF/90.46 KB) Italian (PDF/75.29 KB) (PDF/75.29 … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
PDF/1.27 MB) (PDF/1.27 MB) Italian (PDF/1.2 MB) (PDF/1.2 MB … formally requested by the Italian medicines agency, to examine … -
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National expert: Francesca Renda, Italian Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 28.98 KB | PDF
Nominating authority: Italian Medicines Agency Interest … Country: Italy 1. Employer: Italian Medicines Agency • Start … review of reporting to the Italian Pharmacovigilance data_base … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
PDF/705.31 KB) (PDF/705.31 KB) Italian (PDF/651.97 KB) (PDF/651.97 … -
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Human medicine European public assessment report (EPAR): Telmisartan Actavis
Telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 11, Authorised, Last updated: 24/02/2023
PDF/101.87 KB) (PDF/101.87 KB) Italian (PDF/85.42 KB) (PDF/85.42 … formally requested by the Italian medicines agency, to examine …