2064 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 … designation Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for 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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Second international symposium on biopharmaceutical statistics
Berlin, Germany, from 01/03/2011 to 03/03/2011, Last updated: 18/11/2010international symposium on biopharmaceutical statistics … International Society for Biopharmaceutical Statistics and the International … -
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ICH M9 on biopharmaceutics classification system based biowaivers - Scientific guideline
Last updated: 11/02/2020ICH M9 on biopharmaceutics classification system based … ICH M9 on biopharmaceutics classification system based … M9 Step 2b on biopharmaceutics classification system based …
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Press release: DOR BIOPHARMA UK Ltd withdraws marketing authorisation application for orBec (beclomethasone dipropionate)
Last updated: 23/05/2008DOR BIOPHARMA UK Ltd withdraws marketing … formally notified by DOR BIOPHARMA UK Ltd of its decision to … PRESS RELEASE DOR BIOPHARMA UK Ltd withdraws marketing … -
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European Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs
CCT venues, 40 Bank Street, Canary Wharf, London E14 5NR, 16/12/2016, Last updated: 03/02/2017Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual … conference organised by European Biopharmaceutical Enterprises (EBE), with the … Generic Agenda - EMA / European Biopharmaceutical Enterprises (EBE) fifth annual … -
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Micro, small and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies
European Medicines Agency, London, 16/04/2015, Last updated: 01/06/2015regulatory compliance for biopharmaceuticals and advanced therapies … regulatory compliance for biopharmaceuticals and advanced therapies' aims … regulatory compliance for biopharmaceuticals and advanced therapies PDF … -
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Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1 - Scientific guideline
Last updated: 18/11/2011bioequivalence: presentation of biopharmaceutical and bioanalytical data in … bioequivalence: presentation of biopharmaceutical and bioanalytical data in … CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in …
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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 … treatment of distal renal tubular acidosis On 20 June 2017, orphan … treatment of distal renal tubular acidosis. What is distal renal tubular … -
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,
, 
, Revision: 8, Withdrawn, Last updated: 30/10/2017
Publication details >uniQure biopharma B.V. 8 25/10/2012 uniQure biopharma B.V. Meibergdreef 61 NL-1105 … authorisation holder, uniQure biopharma B.V., not to apply for a … authorisation. uniQure biopharma B.V. confirmed that it did … -
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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: 27/03/2023encephalomyopathy, 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 … -
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Human medicine European public assessment report (EPAR): Exondys
eteplirsen, Muscular Dystrophy, Duchenne
Date of refusal: 06/12/2018,
, Refused, Last updated: 12/12/2018
applied for authorisation, AVI Biopharma International Ltd, requested … -
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Human medicine European public assessment report (EPAR): Doxolipad
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms
Date of refusal: 08/08/2019, Refused, Last updated: 26/08/2019for authorisation is TLC Biopharmaceuticals B.V. The company requested … -
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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 … -
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Human medicine European public assessment report (EPAR): Evarrest
human fibrinogen, human thrombin, Hemostasis
Date of authorisation: 25/09/2013,, Revision: 4, Withdrawn, Last updated: 03/04/2018
Publication details >Omrix Biopharmaceuticals N. V.4 25/09/2013 Leonardo … authorisation holder, Omrix Biopharmaceuticals N. V., which notified the … Sealant Matrix to Omrix Biopharmaceuticals NV. This recommendation will … -
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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: 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): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 21, Authorised, Last updated: 30/05/2023any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … -
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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: 23, Authorised, Last updated: 29/03/2023who 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): Vibativ
telavancin, Pneumonia, Bacterial; Cross Infection
Date of authorisation: 02/09/2011,, Revision: 10, Withdrawn, Last updated: 16/05/2018
Publication details >Theravance Biopharma Ireland Umited10 02/09/2011 … authorisation holder, Theravance Biopharma Ireland Ltd, which notified …