FABRAZYME LABEL

Jul 18, 11
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  • Apr 25, 2011 – This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of Fabrazyme [agalsidase beta (recombinant .
  • Aug 8, 2006 – All 58 patients in the randomized study participated in an .
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  • All 58 patients in the randomized study chose to enroll in an open-label extension study of Fabrazyme at 1.0 mg/kg every two weeks indefinitely. .
  • Aug 11, 2009 – Official Title: A Phase 2, Randomized, Open Label, Dose-Ranging, Multiple Dose Study of Fabrazyme® In Patients With Fabry Disease and With .
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  • Drug Name. Generic Name. Studied Indications or Disease. Approved U.S. Drug Label. Fabrazyme®. agalsidase beta. Fabry disease. Prescribing Info .
  • Aug 18, 2010 – Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984 .
  • All 58 patients enrolled in one of the two studies continued into an open-label extension study of Fabrazyme treatment for up to 54 additional months. .
  • Fabrazyme 35 mg, powder for concentrate for solution for infusion - Summary of . and one open-label extension study in both male and female patients. .
  • Use in children: The safety and efficacy of Fabrazyme were assessed in a multinational, multicenter, uncontrolled, open-label study to evaluate safety, .
  • Uses of agalsidase beta (Fabrazyme®) that are not supported in either this medical policy or the off-label coverage policy are considered .
  • A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric .
  • Jan 6, 2011 – Fabrazyme, Agalsidase beta, 5 mg and 35 mg, Lyophilized Powder for Reconstitution, . open-label study of 15 patients with Fabry's Disease. .
  • Apr 30, 2009 – In accordance with approved labeling, your product will .
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  • Official Title: A Multi-center, Phase 2, Open-Label Study of Fabrazyme ( Recombinant Human a-Galactosidase A) Replacement Therapy in Pediatric Patients With .
  • All 58 patients in the randomized study participated in an open-label extension study of Fabrazyme ® at 1.0 mg/kg every two weeks indefinitely. .
  • Description of the drug Fabrazyme. - patient information, description . For non-prescription products, read the label or package ingredients carefully. .
  • Aug 8, 2006 – All 58 patients continued into an open-label extension study of Fabrazyme® treatment for up to 30 additional months. .
  • This was a multi-center, multi-national, open-label extension trial designed to confirm the safety and effectiveness of Fabrazyme in patients with advanced .
  • Mar 7, 2011 – A Randomized Multicenter Multinational Phase 3B Open-Label Parallel-Group Study of Fabrazyme (Agalsidase Beta) in Treatment-Naïve Male .
  • All 58 patients enrolled in one of the two studies continued into an open-label extension study of Fabrazyme treatment for up to 54 additional months. .
  • How to use Fabrazyme: Use Fabrazyme as directed by your doctor. Check the label on the medicine for exact dosing instructions. Fabrazyme is usually given as .
  • TITLE: FABRAZYME® + ARBS + ACE INHIBITOR TREATMENT (FAACET) STUDY Multi-center, Open-label. Study of the Safety and Efficacy of Control of Proteinuria with .
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  • All 58 patients enrolled in one of the two studies continued into an open-label extension study of Fabrazyme treatment for up to 54 additional months. .
  • 10 postsFabrazyme For Injection - FDA US Commercial Drugs Manufacturers Directory . http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf, .
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  • Oct 29, 2010 – . disease receive the full label-recommended dosage of Genzyme's agalsidase- beta (Fabrazyme) despite the ongoing shortage of the drug,
  • All 58 subjects in the randomized study participated in an open-label extension study of Fabrazyme at 1.0 mg/kg every two weeks indefinitely. .
  • Fabrazyme, - European Drugs Reference Encyclopedia. . agalsidase beta treatment was demonstrated further in the open label extension of this trial. .
  • Detailed drug information for the consumer, includes dosage, Fabrazyme . For non-prescription products, read the label or package ingredients carefully. .
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  • Jun 17, 2008 – Official Title: A Randomized, Multicenter, Multinational .
  • Apr 28, 2011 – All 58 patients enrolled in one of the two studies continued into an open-label extension study of Fabrazyme treatment for up to 54 .
  • A Randomized, Multicenter, Multinational, Phase 3B, Open-label, Parallel-Group Study of Fabrazyme® (agalsidase beta) in Treatment - Naive Male Pediatric .
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  • 2011年2月13日 – All 58 subjects in the randomized study participated in an open-label extension study of Fabrazyme at 1.0 mg/kg every two weeks indefinitely .
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  • Aug 17, 2010 – In vivo testingpromotion of Fabrazyme (agalsidase beta) by Genzyme. . comparing the medicines. open label clinical trial of Fabrazyme .
  • Mar 24, 2011 – The biotech Wednesday disclosed that a lot of its Fabrazyme med, which is used to . Feds Probe Cephalon for Off-Label Treanda Promotion: .
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  • Aug 11, 2009 – Official Title: A Multicenter, Open-label Study of Low Dose Maintenance Treatment of Fabrazyme (Recombinant Human Alpha-Galactosidase A (R-h .
  • Fabrazyme received European Union marketing authorisation in August for use in enzyme . open-label Phase 3 clinical trial extension study of Fabrazyme. .
  • Mar 2, 2011 – All 58 patients enrolled in one of the two studies continued into an open-label extension study of Fabrazyme treatment for up to 54 .

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