mmol/L millimoles per litre NOAEL No observable adverse effect PDE Permitted Daily Exposure PXRD Powder X-ray diffraction QD once daily QTc corrected QT interval on ECG RAAS renin-angiotensin aldosterone system SAE serious adverse event SK serum potassium SPS sodium polystyrene sulfonate TEAE treatment-emergent adverse TDS three times daily ZS sodium zirconium cyclosilicate I. Introduction to product submission Submission details New chemical entity Type of submission: Withdrawn Decision: Date of decision: 13 2017 Date of entry onto ARTG NA Active ingredient: Sodium zirconium cyclosilicate hydrate Product name: Lokelma AstraZeneca Pty Ltd Sponsor’s name and address: PO Box 131 North Ryde NSW 1670 Dose form: Powder, oral Strengths: 5 g and 10 g
mmol/L millimoles per litre NOAEL No observable adverse effect PDE Permitted Daily Exposure PXRD Powder X-ray diffraction QD once daily QTc corrected QT interval on ECG RAAS renin-angiotensin aldosterone system SAE serious adverse event SK serum potassium SPS sodium polystyrene sulfonate TEAE treatment-emergent adverse TDS three times daily ZS sodium zirconium cyclosilicate I. Introduction to product submission Submission details Type of submission: New chemical entity Decision: Withdrawn Date of decision: 13 2017 Date of entry onto ARTG NA Active ingredient: Sodium zirconium cyclosilicate hydrate Product name: Lokelma Sponsor’s name and address: AstraZeneca Pty Ltd PO Box 131 North Ryde NSW 1670 Dose form: Powder, oral Strengths: 5 g and 10 g
auspar-sodium-zirconium-cyclosilicate-hydrate-180129.docx