733 results
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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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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): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015, Revision: 25, Authorised, Last updated: 07/06/2023patients 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): Ocaliva
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): 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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National expert: Nathalie Gault, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 42.23 KB | PDF
- Curriculum Vitae - 25.33 KB | PDF
complication in diabetic acidocetosis of adults in intensive care … -
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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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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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National expert: Jean-Michel Race, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 40.11 KB | PDF
- Curriculum Vitae - 28.98 KB | PDF
2014;228(4):338_43. 2: Lactic acidosis in metformin therapy: searching … 039;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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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: Silvia Berkner, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 27.23 KB | PDF
plasmid pRN1 for Sulfolobus acidocaldarius and Sulfolobus solfataricus … for genetic systems in S. acidocaldarius. Extremophiles, 14: 249_259 … -
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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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Referral: Topamax
topiramate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/06/2009, EC decision date: 01/10/2009, Last updated: 15/12/2009suicidal ideation, and metabolic acidosis (increased acid levels in … suicidal ideation, and metabolic acidosis (increased acid levels in … -
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National expert: Consuelo Pedrós, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 32.6 KB | PDF
Manríquez M, Morros R. Lactic acidosis associated with metformin … -
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Human medicine European public assessment report (EPAR): Ristfor (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 26, Authorised, Last updated: 09/06/2023 -
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Human medicine European public assessment report (EPAR): Jentadueto (updated)
linagliptin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 19/07/2012, Revision: 21, Authorised, Last updated: 07/06/2023 -
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Human medicine European public assessment report (EPAR): Zonisamide Mylan (updated)
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,
, Revision: 9, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Segluromet (updated)
ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018, Revision: 7, Authorised, Last updated: 07/06/2023 -
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord (updated)
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, , Revision: 2, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Komboglyze (updated)
metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 24/11/2011, Revision: 20, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Vokanamet (updated)
canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/04/2014, Revision: 21, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 30/05/2023