№ files_lp_4_process_3_098181
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This document outlines a submission for the PBS listing of fedratinib, detailing its clinical comparison with current therapies for myelofibrosis patients with prior ruxolitinib treatment.
Year: 2025
Region / City: Australia
Subject: Myelofibrosis treatment
Document Type: Pharmaceutical Submission
Organization / Institution: Services Australia
Author: Unknown
Target Audience: Medical Practitioners
Period of Validity: N/A
Approval Date: February 13, 2025
Modification Date: N/A
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
NIVOLUMAB, Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. Infusion 100 mg in 10 mL, Opdivo®, BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD
Year: 2023
Region / City: Australia
Topic: Oncology, Urothelial carcinoma, Immunotherapy
Document type: Medical submission
Organization / Institution: Bristol-Myers Squibb Australia Pty Ltd
Author: Unknown
Target audience: Medical practitioners, healthcare professionals
Period of validity: Ongoing
Approval date: 2023
Date of amendments: N/A
Source: TGA/PBAC Parallel Process
Indication: First-line treatment for unresectable or metastatic urothelial carcinoma
Treatment phase: Initial and Continuing treatment
Condition: Unresectable or metastatic urothelial carcinoma
Treatment criteria: Patient must meet specific clinical and therapeutic criteria
NIVOLUMAB plus IPILIMUMAB, NIVOLUMAB: Injection concentrate for I.V. infusion 100 mg in 10 mL, Injection concentrate for I.V. infusion 40 mg in 4 mL, OPDIVO®; IPILIMUMAB: Injection concentrate for I.V. infusion 200 mg in 40 mL, Injection concentrate for I.V. infusion 50 mg in 10 mL, YERVOY®; Bristol-Myers Squibb Australia Pty Ltd
Year: 2022
Region / City: Australia
Theme: Oncology, Medical Treatment
Document Type: Pharmaceutical Submission
Organization / Institution: Bristol-Myers Squibb Australia Pty Ltd
Author: Not specified
Target Audience: Medical professionals, Oncologists
Period of validity: Ongoing
Approval Date: 4 July 2018
Date of Changes: Not specified
Note: Contextual Description
NIVOLUMAB, Injection concentrate for I.V. infusion 40 mg in 4 mL, 100 mg in 10 mL, Opdivo®, Bristol-Myers Squibb Australia Pty Ltd
Year: 2021
Region / city: Australia
Theme: Cancer treatment
Document type: Submission for Authority Required listing
Organization / institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Bristol-Myers Squibb Australia Pty Ltd
Target audience: Medical practitioners
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
7.07 NIVOLUMAB, Injection concentrate for I.V. infusion, 40 mg in 4 mL, 100 mg in 10 mL, Opdivo®, as monotherapy, or in combination with IPILIMUMAB, Injection concentrate for I.V. infusion, 50 mg in 10 mL, 200 mg in 40 mL, Yervoy®, Bristol-Myers Squibb
Year: 2023
Region / City: Australia
Subject: Cancer Treatment / Immunotherapy
Document Type: Submission
Organ / Institution: Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Bristol-Myers Squibb
Target Audience: Medical professionals, healthcare policy makers, pharmaceutical industry stakeholders
Period of Validity: Ongoing
Approval Date: Not specified
Date of Changes: Not specified
Family Weekly News – Child Development Center for Bristol-Myers Squibb – October 3, 2016
Organization: Child Development Center for Bristol-Myers Squibb
Date: Monday, October 3, 2016
Type of document: Weekly newsletter
Region: United States
Programs mentioned: Preschool/Kindergarten (PS/K)
Events: Picture Day; Parent Partnership Call; Music for PS/K; Field Trip to Windsor Farm; Read for the Record; Harvest Festival; Homefront Food Drive
Workshops: Weekly pregnancy workshop by March of Dimes
Location details: Lawrenceville and Hopewell Child Development Centers
Contacts: Kelli Mueller; Cyndi Guler; Jessica Goldfarb; Kim Murillo
Related platform: Yammer (U.S. Work/Life Programs)
Curriculum reference: Bright Horizons – The World at Their Fingertips®
Audience: Families of enrolled children
Topics: FEDRATINIB Inrebic BRISTOL-MYERS