16684 results
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Human medicine European public assessment report (EPAR): Rixubis
nonacog gamma, Hemophilia B
Date of authorisation: 19/12/2014, Revision: 11, Authorised, Last updated: 26/09/2022Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hemophilia … active substance nonacog gamma. How is Rixubis used? Rixubis … substance in Rixubis, nonacog gamma, is a version of human factor … -
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Press release: Committee for veterinary medicinal products: 68th meeting
CVMP, Last updated: 12/07/2001veterinary medicinal products: 68th meeting … -
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Human medicine European public assessment report (EPAR): Orgalutran
ganirelix, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 16/05/2000, Revision: 24, Authorised, Last updated: 04/04/2023Pregnancy Complications Genital Diseases, Female Infertility Reproductive … Authorised ganirelix Overview This is a summary … medicine. active substance , ganirelix. What is Orgalutran used for … -
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Orphan designation: Adeno-associated virus serotype rh10 containing the human GALC gene for: Treatment of Krabbe disease
Date of designation: 15/10/2021, Positive, Last updated: 18/11/2022rh10 containing the human GALC gene … 16 2.1.10. ganaxolone - EMA/OD/0000061671 … rh10 containing the human GALC gene … -
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Orphan designation: Adeno-associated viral vector serotype 8 containing the human alpha-galactosidase A gene for: Treatment of Fabry disease
Date of designation: 20/03/2017, Positive, Last updated: 13/05/2019containing the human alpha-galactosidase A gene … human alphagalactosidase A gene for treatment of Fabry disease … containing the human alpha- galactosidase A gene for treatment of Fabry disease … -
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Press release: 68th meeting of the Committee for Proprietary Medicinal Products (CPMP)
Last updated: 06/03/200168th meeting of the Committee … Press release 06/03/2001 68th meeting of the Committee … 06/03/2001 CPMP/521/01 corr Generic … -
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006, Revision: 19, Authorised, Last updated: 11/07/2022Diseases and Abnormalities Genetic Diseases, Inborn Metabolism … contains the active substance galsulfase (1 mg/ml). What is Naglazyme … called glycosaminoglycans (GAGs). If the enzyme is not present … -
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Herbal medicinal product: Gentianae radix
Gentiana lutea L., Gentian Root, F: Assessment finalised, Last updated: 22/08/2019Gentianae radix Gastrointestinal disorders … Latin name Gentianae radix English common name Gentian Root Botanical name Gentiana lutea L. Therapeutic area … Gentianae radix Gentiana lutea L Gentian Root … -
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Orphan designation: 6-Chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide (selisistat) for: Treatment of Huntington’s disease
Date of designation: 08/10/2009, Positive, Last updated: 04/02/2022EU/3/09/681 … orphan designation (EU/3/09/681) was granted by the European … and 45 years of age, and gets worse over time. Huntington's … -
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Orphan designation: cholic acid for: Treatment of inborn errors in primary bile acid synthesis responsive to treatment with cholic acid
Date of designation: 29/10/2009, Withdrawn, Last updated: 29/07/2020EU/3/09/683 … orphan designation (EU/3/09/683) was granted by the European … acids is caused by inborn genetic abnormalities. Patients lacking … -
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Orphan designation: N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino]isonicotinamide hydrochloride for: Treatment of pancreatic cancer
Date of designation: 08/10/2009, Withdrawn, Last updated: 12/08/2020EU/3/09/685 … orphan designation (EU/3/09/685) was granted by the European … Commission to Merck KGaA, Germany, for N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino]isonicotinamide … -
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Orphan designation: 5'-O-(trans-9''-octadecenoyl)-1-beta-D-2'-deoxy-2',2'-difluorocytidine for: Treatment of pancreatic cancer
Date of designation: 28/10/2009, Withdrawn, Last updated: 24/06/2013EU/3/09/680 … EU/3/09/680: Orphan designation for the … orphan designation (EU/3/09/680) was granted by the European … -
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Orphan designation: Patupilone for: Treatment of primary peritoneal cancer
Date of designation: 05/11/2009, Withdrawn, Last updated: 11/02/2015EU/3/09/687 … EU/3/09/687: Orphan designation for the … orphan designation (EU/3/09/687) was granted by the European … -
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Orphan designation: Peptides mimicking antigen receptors on autoimmune B cells and autoimmune T cells associated with myasthenia gravis for: Treatment of myasthenia gravis
Date of designation: 09/11/2009, Positive, Last updated: 07/10/2014EU/3/09/689 … EU/3/09/689: Orphan designation for the … orphan designation (EU/3/09/689) was granted by the European … -
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Orphan designation: Masitinib mesilate for: Treatment of pancreatic cancer
Date of designation: 28/10/2009, Positive,EU/3/09/684 … EU/3/09/684: Orphan designation for the … orphan designation (EU//09/684) was granted by the European … -
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Orphan designation: Anti-EphA2 monoclonal antibody conjugated to maleimidocaproyl monomethylauristatin phenylalanine for: Treatment of ovarian cancer
Date of designation: 28/10/2009, Withdrawn, Last updated: 19/11/2010EU/3/09/682 … EU/3/09/682: Orphan designation for the … orphan designation (EU/3/09/682) was granted by the European … -
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Orphan designation: Patupilone for: Treatment of fallopian tube cancer
Date of designation: 05/11/2009, Withdrawn, Last updated: 29/03/2011EU/3/09/688 … EU/3/09/688: Orphan designation for the … -
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Orphan designation: NGR-human tumour necrosis factor for: Treatment of hepatocellular carcinoma
Date of designation: 09/11/2009, Positive, Last updated: 18/11/2009EU/3/09/686 … EU/3/09/686: Orphan designation for the … orphan designation (EU/3/09/686) was granted by the European … -
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Human medicine European public assessment report (EPAR): Galafold (updated)
Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,
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, Revision: 16, Authorised, Last updated: 25/05/2023
Galafold Nervous System Diseases Central … System Sphingolipidoses Genetic Diseases, Inborn Congenital … Diseases and Abnormalities Genetic Diseases, X-Linked Metabolism … -
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Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/2/2010, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Gastro-resistant tablet, Age-appropriate dosage form, other, Age-appropriate dosage form for parenteral use
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: X1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13 … OncologyP/2/2010P/2/2010 Gastro-resistant tablet Age-appropriate dosage … 1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,-22,23,24,25,26,27,28 … -
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Paediatric Committee (PDCO): 6-8 June 2012
European Medicines Agency, London, UK, from 06/06/2012 to 08/06/2012, Last updated: 25/08/2011Paediatric Committee (PDCO): 6-8 June 2012 … Agenda - PDCO agenda of the 6-8 June 2012 meeting PDF icon … 18/07/2012 EMA/PDCO/483938/2012 Generic Minutes - PDCO minutes of … -
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Paediatric Committee (PDCO): 6-8 February 2013
European Medicines Agency, London, UK, from 06/02/2013 to 08/02/2013, Last updated: 21/12/2010Paediatric Committee (PDCO): 6-8 February 2013 … Minutes - PDCO minutes of the 6-8 February 2013 meeting PDF … 25/03/2013 EMA/PDCO/61365/2013 Generic PDCO monthly report of opinions … -
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Paediatric Committee (PDCO): 6-8 November 2013
European Medicines Agency, London, UK, from 06/11/2013 to 08/11/2013, Last updated: 21/12/2010Paediatric Committee (PDCO): 6-8 November 2013 … Paediatric Committee (PDCO): 6-8 November 2013 … -
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Paediatric Committee (PDCO): 6-8 October 2010
European Medicines Agency, London, UK, from 06/10/2010 to 08/10/2010, Last updated: 16/02/2010Paediatric Committee (PDCO): 6-8 October 2010 … Documents PDCO meeting report 6-8 October 2010 PDF icon application/pdf … 15/10/2010 EMA/PDCO/620211/2010 Generic Related information Paediatric … -
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Herbal medicinal product: Juniperi galbulus (pseudo-fructus)
Juniperus communis L., Juniper cone berry, F: Assessment finalised, Last updated: 30/03/2023Juniperi galbulus (pseudo-fructus) Urinary … pseudo-fructus) Urinary tract and genital disorders … Latin name Juniperi galbulus (pseudo-fructus) English …