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PRODUCT MONOGRAPH Master TemplateTemplate date: September 2020 FORXIGA (dapagliflozin propanediol monohydrate)Page 1 of 75 COPYRIGHT 2014-2021 ASTRAZENECA CANADA INCPRODUCT MONOGRAPHINCLUDING PATIENT medication INFORMATIONFORXIGA Dapagliflozin propanediol monohydrateTablets, 5 mg and 10 mg, OralATC Code: A10BK01 Sodium-glucose co-transporter 2 (SGLT2) inhibitorsAstraZeneca Canada Middlegate RoadMississauga, OntarioL4Y of Initial Authorization:Dec 10, 2014 Date of Revision:Aug 06, 2021 Submission Control Number: 248367 FORXIGA is a registered trademark of AstraZeneca AB, used under license byAstraZeneca Canada MONOGRAPH Master TemplateTemplate date: September 2020 FORXIGA (dapagliflozin propanediol monohydrate)Page 2 of 75 COPYRIGHT 2014-2021 ASTRAZENECA CANADA INCRECENT MAJOR LABEL CHANGES1 INDICATIONS08/20212 CONTRAINDICATIONS08/20214 DOSAGE AND ADMINISTRATION, Dosing Considerations08/20214 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment08/20217 WARNINGS AND PRECAUTIONS08/20217 WARNINGS AND PRECAUTIONS, Geriatrics08/2021 TABLE OF CONTENTSS ections or subsections that are not applicable atthe time of authorization are not MAJOR LABEL OF I: HEALTH PROFESSIONAL
Product Monograph Master Template Template date: September 2020 FORXIGA (dapagliflozin propanediol monohydrate) Page 1of 75 COPYRIGHT 2014-2021 ASTRAZENECA CANADA INC PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FORXIGA® Dapagliflozin propanediol monohydrate Tablets, 5 mg and 10 mg, Oral ATC Code: A10BK01
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