№ files_lp_4_process_3_091058
File format: docx
Character count: 37444
File size: 73 KB
Official pharmaceutical document providing detailed clinical, pharmacological, and safety information for healthcare professionals regarding the use, dosage, contraindications, and administration of Oxalip Injection 5 mg/ml.
Year:
2026
Region / city:
International
Subject:
Oncology, Pharmacology
Document type:
Summary of Product Characteristics
Organization / institution:
Pharmaceutical manufacturer
Author:
Not specified
Target audience:
Healthcare professionals
Indications:
Adjuvant treatment of stage III colon cancer, treatment of metastatic colorectal cancer
Dosage form:
Concentrate for solution for infusion
Active substance:
Oxaliplatin
Excipients:
Polyethylene glycol 400
Administration route:
Intravenous infusion
Contraindications:
Hypersensitivity, breastfeeding, severe renal impairment, pre-existing myelosuppression, peripheral neuropathy
Special warnings:
Neurological toxicity, hypersensitivity reactions, peripheral neuropathy, RPLS
Method of preparation:
Dilution in 5% glucose solution before use
Population considerations:
Adults; not indicated for children; dose adjustment for renal impairment; no adaptation for elderly
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
2026
Region:
European Union
Therapeutic Area:
Oncology / Cancer treatment
Document Type:
Product Information / Medicinal Product Monograph
Regulatory Agency:
European Medicines Agency (EMA)
Active Substance:
Bevacizumab
Pharmaceutical Form:
Concentrate for solution for infusion
Indications:
Metastatic colorectal cancer, metastatic breast cancer, nonsmall cell lung cancer, advanced renal cell cancer, epithelial ovarian/fallopian tube/primary peritoneal cancer, recurrent cervical cancer
Dosage and Administration:
Intravenous infusion, dose varies by indication
Target Audience:
Healthcare professionals
Link:
https://www.ema.europa.eu/en/medicines/human/epar/alymsys
Approval Status:
Approved
Year:
2025
Region / City:
Australia
Topic:
Pharmaceutical submission for drug listing
Document Type:
Pharmaceutical submission
Organization:
Janssen-Cilag Pty Ltd
Author:
Not specified
Target Audience:
Healthcare professionals, regulatory authorities
Validity Period:
Not specified
Approval Date:
Not specified
Date of Changes:
March 2025
Note:
Context
Year:
2026
Region / City:
EMEA
Subject:
Pharmaceutical Information
Document Type:
Product Information
Organization / Institution:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare Professionals, Medical Practitioners
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
Year:
2024
Region / City:
Australia
Topic:
Immunization, Respiratory Syncytial Virus (RSV), Vaccines
Document Type:
Submission
Organization:
SANOFI-AVENTIS AUSTRALIA PTY LTD
Author:
Not specified
Target Audience:
Healthcare professionals, policy makers, immunization program administrators
Period of validity:
From 2024
Approval Date:
24 November 2023
Date of Changes:
17 January 2025
Date of Submission:
7 March 2024
Note:
Contextual Description
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
Year:
2025
Region / city:
N/A
Topic:
Intramuscular injection techniques
Document type:
Tip sheet
Organization / institution:
ClinicalKey for Nursing
Author:
Perry, A. G., LaPlante, N., Ostendorf, W. R., & Potter, P. A.
Target audience:
Healthcare professionals
Effective period:
N/A
Approval date:
N/A
Modification date:
N/A
Note:
Year
Theme:
Rheumatology, Methotrexate Therapy, Drug Interaction
Document Type:
Medical Guidelines
Target Audience:
Healthcare Professionals, Specialists
Year:
2020
Region / City:
Australia
Topic:
Pharmaceutical Benefits Scheme (PBS) listing
Document Type:
Committee Submission
Agency:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Committee Secretariat
Target Audience:
Healthcare professionals, PBAC members
Period of Effect:
From May 13, 2020
Approval Date:
May 13, 2020
Modification Date:
Not specified
Year:
2025
Organization:
NHS England, Medicines Procurement and Supply Chain (MPSC)
Type of document:
Invitation to offer / Procurement document
Project title:
NHS National Framework for the supply of Tocilizumab Injection
Offer reference number:
CM/TNS/25/5723
Period of framework:
1 March 2026 to 31 August 2027, with option to extend up to 24 months
Publication date:
7 October 2025
Submission deadline:
5 November 2025, 13:00
Platform for submission:
Atamis / Central Digital Platform
Requirements:
Evergreen assessment, Carbon Reduction Plan, registration on Central Digital Platform
Author / contact:
Katie Noonan, Medicines Procurement Coordinator, NHS England
Region:
United Kingdom
Audience:
Suppliers eligible to participate in NHS procurement
Type of procurement:
Medicines supply
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
Year:
2022
Region / City:
Australia
Subject:
Pharmacology, Pharmaceutical Benefits Scheme (PBS)
Document Type:
Submission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Not specified
Approval Date:
3 June 2022
Date of Changes:
Not specified
Contextual Description:
A regulatory submission detailing the request for listing of dupilumab in new forms for treating severe atopic dermatitis and uncontrolled severe asthma in pediatric patients under the PBS.
Year:
2017
Region / City:
Australia
Subject:
Medical treatment, pharmaceutical submission
Document Type:
Submission for Pharmaceutical Benefits Scheme (PBS) consideration
Organization:
Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AbbVie Pty Ltd.
Target Audience:
Medical professionals, regulatory authorities
Effective Period:
2017–2024
Approval Date:
October 26, 2016
Amendment Date:
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:
2020
Region / City:
Australia
Topic:
Medical Treatment, Pharmaceutical
Document Type:
Submission
Organ / Institution:
Novartis Pharmaceuticals Australia Pty Limited
Author:
Not specified
Target Audience:
Healthcare professionals, policymakers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
UK
Topic:
Healthcare, Medication Guidelines
Document Type:
Medical Protocol
Organisation:
National Ambulance Service Medical Directors (NASMeD)
Author:
Dr. Elizabeth Miller, Dr. Dave Macklin, Mr. Andy Curran, Rosie England, Cathryn James, Dan Haworth, Tracy Rogers, Jo Jenkins, Rosie Furner
Target Audience:
Registered healthcare professionals, Paramedics, Nurses, Midwives
Effective Date:
May 2023
Review Date:
October 2025
Expiry Date:
April 2026
Approval Date:
May 2025
Change History:
Includes updates to drug administration protocols and clinical guidelines