№ lp_1_09735
File format: docx
Character count: 162656
File size: 1385 KB
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.
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2021
Category:
Category 4 Submission
Type of Document:
Submission for PBS Listing
Therapeutic Area:
Multiple Sclerosis
Indication:
Clinically definite relapsing-remitting multiple sclerosis
Medical Condition:
Multiple Sclerosis
Prescriber Type:
Medical Practitioners
Restriction Type:
Authority Required (Streamlined)
Prescribing Instructions:
To be initiated by neurologists, monitoring for signs of progressive multifocal leukoencephalopathy
Comparison:
Natalizumab IV, Ofatumumab
Status:
Approved for listing
Clinical Trials:
REFINE, DELIVER
Treatment Duration:
Ongoing monitoring
Approval:
Therapeutic Goods Administration (TGA) approval on 7 December 2021
Public/Private:
Both Public and Private
Available Brands:
Tysabri
Method of Administration:
Subcutaneous injection
Intended Use:
Subcutaneous administration of natalizumab for multiple sclerosis
Safety Warnings:
Risk of progressive multifocal leukoencephalopathy
Title:
Sample Letter of Medical Necessity for a Treatment-Naïve Patient
Product Name:
TYSABRI® (natalizumab)
Indication:
Relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Target Population:
Adult patients with RMS
Document Type:
Sample letter template and prescribing safety information
Program:
TOUCH® Prescribing Program (REMS)
Risk Information:
Boxed Warning for Progressive Multifocal Leukoencephalopathy (PML)
Contraindications:
History of PML; hypersensitivity to TYSABRI
Safety Topics:
PML, JCV infection, IRIS, herpes encephalitis and meningitis, acute retinal necrosis, hepatotoxicity
Monitoring Requirements:
MRI monitoring, anti-JCV antibody testing, clinical surveillance for neurological symptoms
Intended Users:
Healthcare providers
Purpose:
Support for medical necessity appeals and safety guidance for prescribing
Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical regulation and prescribing requirements
Document Type:
Regulatory submission
Organization:
Biogen Australia Pty Ltd
Author:
Biogen Australia Pty Ltd
Target Audience:
Medical practitioners, healthcare professionals
Action Period:
2021-2022
Approval Date:
31 August 2020
Modification Date:
7 September 2021
Status:
Approved by TGA
Context:
This is a regulatory submission regarding changes to the prescribing instructions for natalizumab (Tysabri®) under the PBS, specifically the removal of mandatory registration with the Tysabri Australian Prescribing Program.
Published Date:
Monday 23 April 2018
Last Reviewed:
Monday 23 April 2018
Authors:
Helen Cliffe; Marium Ahmed; Helen Ford; Mark Igra
Topic:
MRI surveillance and PML screening in multiple sclerosis
Type of Document:
Clinical audit protocol
Target Population:
Adult patients with highly active multiple sclerosis receiving Natalizumab (Tysabri)
Regulatory Framework:
European Medicines Agency recommendations; Summary of Product Characteristics for Tysabri
Clinical Focus:
Progressive multifocal leukoencephalopathy risk monitoring
Imaging Requirements:
Baseline MRI within 3 months prior to treatment; annual MRI surveillance including T1, T2/proton density, FLAIR, DWI and T1 post contrast
Risk Stratification:
JC virus antibody status; treatment duration over 2 years; prior immunosuppressant use
Audit Targets:
100% baseline MRI; 100% annual MRI; 100% protocol adherence
Suggested Cohort Size:
30–100 patients depending on hospital size
Referenced Guidance:
NICE Technology Appraisal TA127 (22 August 2007)
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:
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
Version:
Draft 2.0 | Effective: //_____ | Owner: Director of Special Education / 504 Coordinator | Approved by: __________________________
Year:
Draft 2.0
Region / City:
Midland ISD
Subject:
Special Education, Section 504
Document Type:
Manual
Organization / Institution:
Midland Independent School District
Author:
Director of Special Education
Target Audience:
School staff, administrators, special education professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Contextual description:
A procedural manual for special education and Section 504 practices in Midland ISD, providing detailed operational steps for child find, referrals, evaluations, and compliance with federal and state regulations.