756 results
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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): 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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Human medicine European public assessment report (EPAR): Azopt
brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 26, Authorised, Last updated: 11/07/2022disease or hyperchloraemic acidosis (excess acid in the blood … disease or hyperchloraemic acidosis (excess acid in the blood … -
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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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Human medicine European public assessment report (EPAR): Aclasta (updated)
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): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
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, Revision: 15, Authorised, Last updated: 04/01/2023
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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
tests. Cases of metabolic acidosis (when the body produces more … -
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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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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 13/12/2022body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. For more information, please … -
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Human medicine European public assessment report (EPAR): Viread (updated)
tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections
Date of authorisation: 04/02/2002, Revision: 58, Authorised, Last updated: 04/01/2023body fat changes and lactic acidosis with HIV medicines 23/10/2015 … e.g. pancreatitis, lactic acidosis). Based on the new clinical … of pancreatitis and lactic acidosis have been reported with the … -
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Referral: Gadolinium-containing contrast agents
gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide, gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017 -
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National expert: Jean-Michel Race, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.27 KB | PDF
- Curriculum Vitae - 19.82 KB | PDF
2014;228(4):338-43. 2: Lactic acidosis in metformin therapy: searching … of 'metformin-associated lactic acidosis'. Lalau JD, Race JM. Diabetes … Feb;27(1):24-8. 4: Metformin and lactic acidosis in diabetic humans. Lalau … -
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National expert: Nathalie Gault, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 81.35 KB | PDF
- Curriculum Vitae - 17.27 KB | PDF
complication in diabetic acidocetosis of adults in intensive care … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020treatment of distal renal tubular acidosis, a rare genetic disorder that … -
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National expert: Consuelo Pedrós, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 22.98 KB | PDF
Manriquez M, Morros R. Lactic acidosis associated with metformin … -
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Orphan designation: Dantrolene sodium for: Treatment of malignant hyperthermia
Date of designation: 19/11/2014, Positive, Last updated: 16/01/2015arrhythmias (irregular heart beat), acidosis (high blood levels of acid … irregular heart beat), acidosis (high blood levels of acid … -
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Orphan designation: Fomepizole for: Treatment of methanol poisoning
Date of designation: 30/05/2001, Withdrawn, Last updated: 06/05/2011leads to a severe metabolic acidosis (a disorder of the acid-base … leads to a severe metabolic acidosis (a disorder of the acid-base … -
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National expert: Silvia Berkner, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 19 KB | PDF
plasmid pRN1 for Sulfolobus acidocaldarius and Sulfolobus solfataricus … promoters for genetic systems in S. acidocaldarius. Extremophiles, 14: 249-259. 10 … -
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Human medicine European public assessment report (EPAR): Tygacil
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 34, Authorised, Last updated: 11/10/2022Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,
, Revision: 15, Withdrawn, Last updated: 09/07/2021
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy …