№ lp_1_2_37089
File format: docx Character count: 39702 File size: 94 KB
The document is a pharmaceutical submission outlining the proposed inclusion of infliximab (Remsima® SC) for rheumatoid arthritis treatment in the PBS, detailing dosage schedules, proposed restrictions, and supporting evidence.
Year: 2022
Region / city: Australia
Theme: Rheumatoid Arthritis, Pharmaceutical submission
Document type: Submission for PBS listing
Organization / institution: Celltrion Healthcare Australia Pty Ltd
Author: Celltrion Healthcare Australia Pty Ltd
Target audience: Health professionals, regulators
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
INFLIXIMAB, Solution for injection 120 mg in 1 mL pre-filled pen, Solution for injection 120 mg in 1 mL pre-filled syringe, Remsima® SC, CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Year: 2021
Region / City: Australia
Topic: Pharmaceutical Submission
Document Type: Regulatory Submission
Agency / Institution: PBAC
Author: CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Target Audience: Healthcare professionals, regulatory authorities
Effective Period: 2021 and ongoing
Approval Date: 25 August 2021
Date of Changes: March 2022
INFLIXIMAB, Solution for injection 120 mg in 1 mL pre-filled pen, Solution for injection 120 mg in 1 mL pre-filled syringe, Remsima® SC, CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Year: 2021
Region / City: Australia
Topic: Pharmaceutical Submission
Document Type: Regulatory Submission
Agency / Institution: PBAC
Author: CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Target Audience: Healthcare professionals, regulatory authorities
Effective Period: 2021 and ongoing
Approval Date: 25 August 2021
Date of Changes: March 2022
Request for Prior Authorization to Increase Infliximab Dose for Crohn’s Disease Patient
Year: Not specified
Region / City: Not specified
Topic: Infliximab dose escalation in Crohn’s disease treatment
Document type: Medical request letter
Institution / Organization: Not specified
Author: Not specified
Target audience: Insurance company
Period of validity: Not specified
Approval date: Not specified
Date of modifications: Not specified
INFLIXIMAB, Solution for injection 120 mg in 1 mL pre-filled pen, Solution for injection 120 mg in 1 mL pre-filled syringe, Remsima® SC, CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Year: 2021
Region / City: Australia
Topic: Pharmaceutical Submission
Document Type: Regulatory Submission
Agency / Institution: PBAC
Author: CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Target Audience: Healthcare professionals, regulatory authorities
Effective Period: 2021 and ongoing
Approval Date: 25 August 2021
Date of Changes: March 2022
Request for Prior Authorization for Infliximab Treatment
Document Type: Prior Authorization Request Letter
Subject: Authorization for intravenous Infliximab treatment
Medication: Infliximab
Request Type: Standard or Expedited
Addressee: Medical Director or Prior Authorization Reviewer
Author: Healthcare Provider
Related Information: Diagnosis, ICD Code, Dose and Frequency
Supporting Documentation: Prescribing Information, Peer-Reviewed Articles, Clinical Guidelines
Purpose: Coverage and Reimbursement Approval
Clinical Content: Patient Diagnosis, Treatment History, Prognosis, Rationale for Treatment
Site of Service: Inpatient or Outpatient Medical Facility
Infliximab Protocol
Year: 2020
Region / City: Naas, Ireland
Topic: Healthcare, Medical Protocol
Document Type: Protocol
Organization: Naas General Hospital
Author: Joanna Rea
Target Audience: Gastroenterology team, Clinical Nurse Manager, Nursing staff, IBD Clinical Nurse Specialist
Period of Validity: January 2023
Approval Date: 14th of January 2020
Date of Revision: January 2023
Date of Update: Not specified
Keywords: Infliximab, infusion, protocol, healthcare, patient safety, staff training, adverse events, gastroenterology
INFLIXIMAB (biosimilar) injection, 100mg, Inflectra®, Hospira
Year: 2015
Region / city: Australia
Subject: Pharmaceutical Submissions, Biosimilars
Document Type: Application for PBS Listing
Organization / Institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Hospira
Target Audience: Healthcare professionals, regulatory authorities, pharmaceutical industry
Period of validity: Ongoing
Approval Date: N/A
Date of changes: N/A
The Use of Infliximab in IVIG-Resistant Kawasaki Disease
Year: 2022
Region / City: USA
Topic: Kawasaki Disease Treatment
Document Type: Research Article
Organization / Institution: Multiple Medical Centers
Author: Kaitlyn Krebushevski
Target Audience: Pediatricians, Researchers
Period of Action: Ongoing
Approval Date: January 2022
Modification Date: Not specified
Methodology: Literature Review, Meta-Analysis, Randomized Control Trials
Topics: Remsima CELLTRION Infliximab