№ lp_1_2_44311
File format: docx
Character count: 117448
File size: 791 KB
Year:
2022
Region / City:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission
Agency / Institution:
PBAC
Author:
Janssen-Cilag Pty Ltd
Target audience:
Healthcare professionals, pharmaceutical regulators
Period of validity:
N/A
Approval date:
May 2020
Date of last update:
March 2022
Context:
This document is a pharmaceutical submission requesting PBS listing for ustekinumab in the treatment of moderate to severe ulcerative colitis.
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The product description is provided for reference. Actual content and formatting may differ slightly.
Document type:
Prior authorization request letter
Medical specialty:
Gastroenterology
Condition:
Ulcerative colitis
Medication:
STELARA® (ustekinumab)
Request type:
Standard or expedited authorization
Intended recipient:
Medical Director of payer organization
Healthcare setting:
Hospital outpatient, outpatient clinic, private practice, or other
Purpose:
Formulary exception and coverage authorization
Supporting materials referenced:
Prescribing information, clinical guidelines, peer-reviewed literature
Source type:
Clinical administrative correspondence
Year:
[Insert Year]
Region / City:
[Insert City, State ZIP]
Topic:
Medical treatment authorization
Document type:
Request letter
Organization / Institution:
[Insert Organization Name]
Target audience:
Medical Director, Payer (Insurance Company)
Period of validity:
[Insert Start Date] - [Insert End Date]
Approval date:
[Insert Date of Approval]
Amendment date:
[Insert Date of Changes if any]
Year:
Not specified
Region / City:
Not specified
Theme:
Pharmaceutical treatment
Document Type:
Product Information
Organization / Institution:
Janssen Biotech, Inc
Author:
Not specified
Target Audience:
Healthcare professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / City:
European Union
Subject:
Pharmaceutical Product Information
Document Type:
Pharmaceutical Summary
Organization:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Period of validity:
Ongoing
Approval Date:
2026
Date of Modifications:
2026
Contextual Description:
The document outlines the product characteristics, indications, dosage, administration guidelines, and precautions for the pharmaceutical product Tysabri, as approved by the European Medicines Agency.
Year:
2023
Region / city:
Smithville, MO, USA
Topic:
Chemical safety, hazard identification, first-aid measures
Document type:
Safety Data Sheet
Organization:
Thornell Corporation
Author:
Thornell Corporation
Target audience:
Manufacturers, safety personnel, emergency responders
Effective period:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2022
Region / City:
Australia
Topic:
Medical treatment approval and submission for pembrolizumab and lenvatinib
Document type:
Submission for drug listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Therapeutic Goods Administration (TGA)
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Medical professionals, health regulators
Period of validity:
2022 onward
Approval date:
August 10, 2021
Amendment date:
Not specified
Year:
2023
Region / City:
Australia
Theme:
Oncology, Pharmaceutical
Document Type:
Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, policymakers
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Oncology / Colorectal Cancer Treatment
Document Type:
Medical submission
Agency / Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Medical practitioners
Effective Period:
Ongoing
Approval Date:
Not provided
Date of Revision:
Not provided
Year:
2024
Region / City:
Australia
Topic:
Oncology / Cancer Treatment
Document Type:
Pharmaceutical Submission
Organization:
Merck Sharp & Dohme
Author:
Merck Sharp & Dohme
Target Audience:
Healthcare professionals, regulatory bodies, pharmaceutical industry
Effective Period:
From September 2024
Approval Date:
Pending
Date of Changes:
September 2024
Context:
A submission by Merck Sharp & Dohme to request a multi-indication listing for pembrolizumab to treat advanced or metastatic cancers under the Pharmaceutical Benefits Scheme in Australia.
Year:
2023
Region / city:
Europe
Topic:
Neurology, Immunology
Document type:
Product Information
Author:
European Medicines Agency
Target audience:
Healthcare professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
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
Year:
2024
Region / City:
European Union
Topic:
Product Information
Document Type:
Pharmaceutical Product Information
Organization / Institution:
European Medicines Agency
Author:
Not specified
Target Audience:
Healthcare professionals
Period of Effect:
Indefinite until new safety information is available
Approval Date:
2024
Date of Changes:
2024
Year:
No data
Region / City:
No data
Topic:
Chemical safety
Document type:
Safety data sheet
Organization / Institution:
Thornell Corporation
Author:
No data
Target audience:
Workers handling chemicals
Effective period:
No data
Approval date:
No data
Revision date:
No data
Year:
2023
Region / City:
Smithville, MO, USA
Topic:
Chemical Safety, Product Identification, Hazard Classification
Document Type:
Safety Data Sheet
Organization / Institution:
Thornell Corporation
Author:
Thornell Corporation
Target Audience:
General public, workers handling chemical products
Effective Period:
Not specified
Approval Date:
Not specified
Revision Date:
Not specified
Year:
2023
Region / city:
Smithville, MO
Topic:
Chemical safety, Deodorizer
Document type:
Safety Data Sheet
Organization / institution:
Thornell Corporation
Author:
Thornell Corporation
Target audience:
Workers handling chemicals, Emergency responders
Effective period:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Subject:
Pharmaceutical product information
Document type:
Approved product information
Organ / Institution:
European Medicines Agency (EMA)
Target audience:
Healthcare professionals
Contextual description:
Detailed product information for IMFINZI, including indications for various cancers and recommended dosages, aimed at healthcare providers involved in cancer treatment.
Year:
2024
Region / City:
Australia
Subject:
Nivolumab and ipilimumab treatment for unresectable malignant mesothelioma
Document type:
Submission report
Organ / Institution:
PBAC, DUSC, TGA
Author:
Unknown
Target audience:
Pharmaceutical regulators, healthcare professionals
Period of validity:
2021-2024
Approval date:
July 2021
Date of changes:
March 2024
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
Year:
2021
Region / City:
South Africa
Topic:
Occupational Health and Safety
Document Type:
Form
Organization:
Department of Labour
Author:
Compensation Commissioner
Target Audience:
Employers, Consultants
Period of Validity:
01/03/2021 - 28/02/2023
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2023
Region / city:
Global
Topic:
Mobile device technical adaptation, customisation
Document type:
Industry specification
Organisation / institution:
GSMA
Author:
GSM Association
Target audience:
Manufacturers, MNOs, MVNOs
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified