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MIGALASTAT HYDROCHLORIDE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • At a dose approximately 8 times the recommended dose, GALAFOLD did not prolong the QT interval to any clinically relevant extent.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
557
38381030

Odds Ratio = 0.0

Drug Property Information



ATC Code(s):
  • A16AX14 - migalastat hydrochloride
    • A16AX - Various alimentary tract and metabolism products
    • A16A - OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
    • A16 - OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
    • A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:MIGALASTAT HYDROCHLORIDE
Active Ingredient UNII:CLY7M0XD20
Drugbank ID:DB05018
PubChem Compound:176077
CTD ID: C090092
PharmGKB:
CAS Number:108147-54-2
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
  • 61.5 mg/day A16AX14
Chemical Structure:
SMILE Code:
OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O

Reference

N/A

Disclaimer:

The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

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