AusPAR: Infliximab (rmc)

Australian Public Assessment Report

AusPAR

AusPAR: Infliximab (rmc) [PDF, 1.66 MB]

AusPAR: Infliximab (rmc) [DOCX, 1.63 MB]

Attachment: Delegate’s reports from clinical units 1 and 4 [PDF, 410.27 KB]

Attachment: Delegate’s reports from clinical units 1 and 4 [DOCX, 128.75 KB]

Attachment: Product Information Infliximab (rmc) (Remsima) [PDF, 636.78 KB]

Attachment: Product Information Infliximab (rmc) (Remsima) [DOCX, 213.09 KB]

Attachment: Product Information Infliximab (rmc) (Emisima) [PDF, 639.23 KB]

Attachment: Product Information Infliximab (rmc) (Emisima) [DOCX, 217.08 KB]

Attachment: Product Information Infliximab (rmc) (Flixceli) [PDF, 570.05 KB]

Attachment: Product Information Infliximab (rmc) (Flixceli) [DOCX, 213.92 KB]

Attachment: Product Information Infliximab (rmc) (Inflectra) [PDF, 560.85 KB]

Attachment: Product Information Infliximab (rmc) (Inflectra) [DOCX, 213.62 KB]

Device/Product Name

Remsima, Emisima, Flixceli, Inflectra

Active ingredients

Infliximab (rmc)

AusPAR Date

3 June 2020

Published

6 July 2020

Submission Number

PM-2013-03247-1-3

Submission Type

An application to register a biosimilar

Decision

Approved

Product types

Prescription medicines