№ lp_1_15924
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Vedolizumab submission for listing as a treatment for chronic pouchitis in patients who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for ulcerative colitis.
Year: 2023
Region / city: Australia
Topic: Vedolizumab submission for chronic pouchitis treatment
Document type: Submission for listing of medicinal product
Agency: Therapeutic Goods Administration (TGA)
Author: Takeda Pharmaceuticals Australia Pty. Ltd.
Target audience: Healthcare professionals, regulatory authorities
Effective period: From 29 June 2023
Approval date: 29 June 2023
Modification date: N/A
Price: 8 / 10 USD
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Vedolizumab, Injection 108 mg in 0.68 mL pre-filled syringe, Injection 108 mg in 0.68 mL pre-filled pen, Entyvio®, Takeda Pharmaceuticals Australia Pty Ltd.
Year: 2020
Region / City: Australia
Theme: Pharmaceutical submission, medical treatment
Document Type: Submission
Organization / Institution: Takeda Pharmaceuticals Australia Pty Ltd
Author: Takeda Pharmaceuticals Australia Pty Ltd
Target Audience: Medical practitioners, gastroenterologists
Period of Validity: Not specified
Approval Date: 12 May 2020
Modification Date: Not specified
Registration Status: Registered by TGA
Clinical Claim: VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications: Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings: PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions: Specific guidelines for initiating subcutaneous therapy
Administrative Advice: Applications for authorisation under PBS can be made online or by phone
Contextual Description: A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Vedolizumab, Injection 108 mg in 0.68 mL pre-filled syringe, Injection 108 mg in 0.68 mL pre-filled pen, Entyvio®, Takeda Pharmaceuticals Australia Pty Ltd.
Year: 2020
Region / City: Australia
Theme: Pharmaceutical submission, medical treatment
Document Type: Submission
Organization / Institution: Takeda Pharmaceuticals Australia Pty Ltd
Author: Takeda Pharmaceuticals Australia Pty Ltd
Target Audience: Medical practitioners, gastroenterologists
Period of Validity: Not specified
Approval Date: 12 May 2020
Modification Date: Not specified
Registration Status: Registered by TGA
Clinical Claim: VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications: Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings: PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions: Specific guidelines for initiating subcutaneous therapy
Administrative Advice: Applications for authorisation under PBS can be made online or by phone
Contextual Description: A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Guidance on Completing a Letter of Rejected Claim for ENTYVIO
Year: 2026
Region / City: USA
Subject: Medical insurance claims
Document type: Template
Organization / Institution: Healthcare provider
Author: Not specified
Target audience: Physicians, healthcare providers
Period of validity: Not specified
Date of approval: Not specified
Date of revisions: 08/24
Context description: A medical document template that provides guidance on how to complete a rejected claim letter for ENTYVIO® treatment.
Brentuximab vedotin Powder for I.V. infusion 50 mg, Adcetris®, Takeda Pharmaceuticals Australia Pty Ltd
Year: 2018
Region / City: Australia
Topic: Pharmaceutical Submission, Cancer Treatment
Document Type: Submission
Organization / Institution: Takeda Pharmaceuticals Australia Pty Ltd
Author: Takeda Pharmaceuticals Australia Pty Ltd
Target Audience: Healthcare professionals, PBAC
Period of Validity: Ongoing
Approval Date: 23 May 2018
Date of Amendments: Not specified
Vedolizumab, Injection 108 mg in 0.68 mL pre-filled syringe, Injection 108 mg in 0.68 mL pre-filled pen, Entyvio®, Takeda Pharmaceuticals Australia Pty Ltd.
Year: 2020
Region / City: Australia
Theme: Pharmaceutical submission, medical treatment
Document Type: Submission
Organization / Institution: Takeda Pharmaceuticals Australia Pty Ltd
Author: Takeda Pharmaceuticals Australia Pty Ltd
Target Audience: Medical practitioners, gastroenterologists
Period of Validity: Not specified
Approval Date: 12 May 2020
Modification Date: Not specified
Registration Status: Registered by TGA
Clinical Claim: VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications: Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings: PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions: Specific guidelines for initiating subcutaneous therapy
Administrative Advice: Applications for authorisation under PBS can be made online or by phone
Contextual Description: A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Proposal Template for Non-Confidential Submissions to Takeda
Year: 2023
Organization: Takeda Pharmaceutical Company
Document Type: Proposal Template
Intended Users: Principal Investigators and Co-Investigators
Field of Interest: Medical and Pharmaceutical Research
Submission Requirements: Maximum 4 pages, file size ≤ 5MB
Content Sections: Project Title, Executive Summary, Keywords, Project Description, Background and Rationale, Research Plan and Timelines, Work Packages, Additional Background Information, Publications, Patent Applications, Competitive Research Funding
Contact Email: [email protected]
Date Format: DD/MM/2023
Topics: VEDOLIZUMAB Entyvio Takeda