AusPAR: Ertugliflozin and Ertugliflozin / Sitagliptin and Ertugliflozin / Metformin

Australian Public Assessment Report

AusPAR

AusPAR: Ertugliflozin and Ertugliflozin / Sitagliptin and Ertugliflozin / Metformin [PDF, 1.55 MB]

AusPAR: Ertugliflozin and Ertugliflozin / Sitagliptin and Ertugliflozin / Metformin [Word, 1.54 MB]

Attachment: Product Information: Ertugliflozin / Sitagliptin [PDF, 653.84 KB]

Attachment: Product Information: Ertugliflozin / Sitagliptin [Word, 510.05 KB]

Attachment: Product Information: Ertugliflozin [PDF, 502.13 KB]

Attachment: Product Information: Ertugliflozin [Word, 534.81 KB]

Attachment: Product Information: Ertugliflozin / Metformin [PDF, 529.74 KB]

Attachment: Product Information: Ertugliflozin / Metformin [Word, 454.03 KB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin [PDF, 4.91 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin [Word, 13.58 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin Part 2 [PDF, 4.6 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin Part 2 [Word, 10.19 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin / Metformin [PDF, 2.14 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin / Metformin [Word, 4.67 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin / Sitagliptin [PDF, 1.67 MB]

Attachment: Extract from Clinical Evaluation: Ertugliflozin / Sitagliptin [Word, 3.25 MB]

Device/Product Name

Steglatro, Steglujan, Segluromet

Active ingredients

Ertugliflozin and Ertugliflozin / Sitagliptin and Ertugliflozin / Metformin

AusPAR Date

5 February 2019

Published

27 March 2019

Submission Number

PM-2017-01328-1-5 PM-2017-01329-1-5 PM-2017-01330-1-5

Submission Type

New chemical entity/ new drug combinations

Decision

Approved