548 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of first decision: 16/01/2014, Positive, Last updated: 23/01/2014Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … designation 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-(2,6-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-(2,6-diamino-hexanoylamino)- 2,6-diamino-hexanoic … -
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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 HIV medicines … body fat changes and lactic acidosis with HIV medicines 23 … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of first decision: 20/06/2017, Positive, Last updated: 17/07/2017treatment of distal renal tubular acidosis. Expand section Collapse section … 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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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 first decision: 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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Human medicine European public assessment report (EPAR): Xigduo
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 16, Authorised, Last updated: 12/02/2020any 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: (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 first decision: 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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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: XTreatment of renal tubular acidosis Oral use Advicenne Pharma … treatment of renal tubular acidosis PDF icon application/pdf … treatment of renal tubular acidosis On 15 August 2014, the … -
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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): Azarga
brinzolamide, timolol maleate, Glaucoma, Open-Angle, Ocular Hypertension
Date of authorisation: 25/11/2008, Revision: 13, Authorised, Last updated: 17/08/2020airways); 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): Simbrinza
brinzolamide, brimonidine tartrate, Ocular Hypertension, Glaucoma, Open-Angle
Date of authorisation: 18/07/2014, Revision: 7, Authorised, Last updated: 11/06/2020patients 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 (updated)
Date of first decision: 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): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 16, Authorised, Last updated: 24/02/2021any 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): Synjardy
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015,
, Revision: 17, Authorised, Last updated: 21/10/2020
patients 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): Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 22, Authorised, Last updated: 06/07/2020been seen including lactic acidosis (excess lactic acid in the … been seen including lactic acidosis (excess lactic acid in the … -
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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): Glubrava
metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 11/12/2007, Revision: 16, Authorised, Last updated: 12/08/2019own 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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Human medicine European public assessment report (EPAR): Competact
pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 28/07/2006, Revision: 17, Authorised, Last updated: 18/06/2019own 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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Human medicine European public assessment report (EPAR): Azopt
brinzolamide, Glaucoma, Open-Angle, Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 24, Authorised, Last updated: 11/07/2018disease 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): Libmeldy
autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, 
, Authorised, Last updated: 22/12/2020
of infection), metabolic acidosis (imbalance in the body’s … of infection), metabolic acidosis (imbalance in the body’s … -
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 25/02/2021body fat changes and lactic acidosis with HIV medicines 23/10/2015 … readily available. Lactic acidosis Lactic acidosis, usually associated with hepatomegaly … -
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 33, Authorised, Last updated: 25/02/2021body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Ziagen (updated)
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 42, Authorised, Last updated: 24/02/2021body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 45, Authorised, Last updated: 25/02/2021body fat changes and lactic acidosis with HIV medicines 23/10/2015 … -
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Orphan designation: Diclofenamide for: Treatment of periodic paralysis
Date of first decision: 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 …