901 results
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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: 14/10/2016complication called lactic acidosis, which occurs when naturally … risk of developing lactic acidosis as their kidneys do not remove … and analyse future lactic acidosis cases and report these during … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, Potassium hydrogen carbonate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001357-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 07/12/2018, Last updated: 19/02/2019, Compliance check: V, 15/11/2019Treatment of renal tubular acidosis Route(s) of administration … treatment of renal tubular acidosis On 15 August 2014, the … treatment of renal tubular acidosis (EMEA-001357-PIP01-12 … -
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Human medicine European public assessment report (EPAR): Stocrin
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 49, Authorised, Last updated: 25/04/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Emtriva
emtricitabine, HIV Infections
Date of authorisation: 24/10/2003, Revision: 33, Authorised, Last updated: 18/04/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Azopt
brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 28, Authorised, Last updated: 29/03/2023disease or hyperchloraemic acidosis (excess acid in the blood … disease or hyperchloraemic acidosis (excess acid in the blood … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Simbrinza
brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle
Date of authorisation: 18/07/2014, Revision: 10, Authorised, Last updated: 19/12/2022patients with hyperchloraemic acidosis (excess acid in the blood … patients with hyperchloraemic acidosis (excess acid in the blood … -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 60, Authorised, Last updated: 29/11/2022body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Veterinary medicine European public assessment report (EPAR): VarroMed
oxalic acid dihydrate, formic acid, Bees
Date of authorisation: 02/02/2017, Revision: 3, Authorised, Last updated: 11/01/2022 -
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Orphan designation: Diclofenamide for: Treatment of periodic paralysis
Date of designation: 17/02/2016, Positive, Last updated: 26/04/2021condition known as 'metabolic acidosis'), which studies show can help … -
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Orphan designation: Diclofenamide for: Treatment of periodic paralysis
Date of designation: 27/06/2016, Positive, Last updated: 26/07/2016condition known as 'metabolic acidosis'), which studies show can help … condition known as ‘metabolic acidosis’), which studies show can help … -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.64 KB | PDF
- Curriculum Vitae - 31.8 KB | PDF
“Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell’attivatore della precallicreina in soluzioni di albumina umana” (Abs … -
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National expert: Maria da Graca Ribeiro Campos, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 39.36 KB | PDF
- Curriculum Vitae - 240.74 KB | PDF
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Human medicine European public assessment report (EPAR): Sustiva (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 48, Authorised, Last updated: 25/05/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
, 
, 
, Revision: 16, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Viramune
nevirapine, HIV Infections
Date of authorisation: 04/02/1998, Revision: 44, Authorised, Last updated: 21/04/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Eucreas
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 14/11/2007, Revision: 23, Authorised, Last updated: 29/03/2023who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … information on the risk of lactic acidosis. These patients form a large … -
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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 03/03/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Truvada
emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 20/02/2005, Revision: 46, Authorised, Last updated: 02/02/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Aclasta
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 31, Authorised, Last updated: 16/01/2023 -
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Human medicine European public assessment report (EPAR): Exjade
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,, Revision: 51, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Eviplera
emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 27/11/2011, Revision: 25, Authorised, Last updated: 13/12/2022body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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National expert: Emilia Cercenado Mansilla, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.48 KB | PDF
- Curriculum Vitae - 468.19 KB | PDF