802 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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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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Opinion/decision on a Paediatric investigation plan (PIP): Latuda, Lurasidone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001230-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.p.A … Tel. +3906780531 E-mail: angeliniregulatoryaffairs@angelinipharma.com Decision type PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): benzydamine (hydrochloride), econazole nitrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002143-PIP01-17, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Pessary
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: XAziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … 0691045249 E-mail: ma.gatto@angelini.it ; m.gatto angelini.it W: decision granting a … Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride), gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002263-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … 0691045249 E-mail: m.gatto@angelini.it W: decision granting … Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002142-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: XAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F - S.p.A … 0691045249 E-mail: m.gatto@angelini.it P: decision agreeing on … Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … -
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Human medicine European public assessment report (EPAR): Ontozry
cenobamate, Epilepsy
Date of authorisation: 26/03/2021,
, Revision: 4, Authorised, Last updated: 08/09/2022
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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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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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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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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): Latuda
lurasidone, Schizophrenia
Date of authorisation: 21/03/2014, Revision: 25, Authorised, Last updated: 17/03/2022 -
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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: 25, Authorised, Last updated: 09/11/2022who 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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Human medicine European public assessment report (EPAR): Eucreas
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 14/11/2007, Revision: 22, Authorised, Last updated: 08/11/2022who 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): Azarga
brinzolamide, timolol maleate, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 25/11/2008, Revision: 16, Authorised, Last updated: 11/10/2022airways); 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): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, 
, Revision: 5, Authorised, Last updated: 12/09/2022
of infection), metabolic acidosis (imbalance in the body’s … of infection), metabolic acidosis (imbalance in the body’s …