711 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … with distal renal tubular acidosis (dRTA), a disease in which … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. … -
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Human medicine European public assessment report (EPAR): Bondenza (previously Ibandronic Acid Roche)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 16, Withdrawn, Last updated: 13/05/2013Roche)EMEA/H/C/000502ibandronic acidibandronic acidOsteoporosis, PostmenopausalM05BA06 Publication … -
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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. The sponsor’s address was … What is distal renal tubular acidosis? Distal renal tubular acidosis is a kidney disease in which … type of distal renal tubular acidosis, usually first detected in … -
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Human medicine European public assessment report (EPAR): Ebymect
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 17, Authorised, Last updated: 28/01/2022any 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
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 18, Authorised, Last updated: 28/01/2022any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … -
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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 … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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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: 02/10/2015encephalomyopathy, 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 … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Bonviva
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 28, Authorised, Last updated: 29/03/2021 -
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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): 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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Human medicine European public assessment report (EPAR): Simbrinza
brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle
Date of authorisation: 18/07/2014, Revision: 9, Authorised, Last updated: 25/04/2022patients with hyperchloraemic acidosis (excess acid in the blood … patients with hyperchloraemic acidosis (excess acid in the blood … -
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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): Atripla
efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 13/12/2007, Revision: 36, Withdrawn, Last updated: 21/01/2022body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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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: 15, Authorised, Last updated: 17/11/2021airways); 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): 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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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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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: 24, Authorised, Last updated: 10/03/2022who 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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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): Azopt
brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 25, Authorised, Last updated: 17/11/2021disease 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): Zomarist
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 22, Authorised, Last updated: 10/11/2021who 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): Eucreas
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 14/11/2007, Revision: 21, Authorised, Last updated: 28/10/2021who 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 …