№ lp_1_2_67177
File format: docx Character count: 15720 File size: 59 KB
Year: 2016
Region / City: Australia
Topic: Influenza Vaccination
Document Type: Regulatory Submission
Organ / Institution: PBAC, TGA
Author: Seqirus
Target Audience: Healthcare professionals, regulatory bodies
Period of Validity: Not specified
Approval Date: Not specified
Amendment Date: Not specified
Clinical Trials: Yes
Main Comparator: Fluarix® Tetra
Outcome: Non-inferiority of Afluria® Quad
Context: The document outlines the submission and evaluation of Afluria® Quad for listing on the National Immunisation Program in Australia, comparing it with existing vaccines.
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Human Papillomavirus 9-Valent Vaccine Injection 0.5mL, pre-filled syringe Gardasil® 9, Seqirus
Year: 2015
Region / City: Australia
Topic: Immunization, HPV Vaccine
Document Type: Health Policy
Organization / Institution: Pharmaceutical Benefits Advisory Committee (PBAC)
Author: PBAC
Target Audience: Health professionals, policymakers, researchers
Period of validity: Ongoing from 2015
Date of approval: June 29, 2015
Date of amendments: January 2017
Inactivated trivalent influenza vaccine (Split Virion) suspension for injection, 180mcg single dose in 0.5mL, Fluzone High-Dose, Australia, 2017–2018
Year: 2017
Country: Australia
Vaccine type: Inactivated trivalent influenza vaccine (TIV-HD)
Manufacturer: Sanofi-Aventis Australia Pty Ltd
Product form: Suspension for injection, 180mcg single dose in 0.5mL
Regulatory approval: TGA registration December 2017
Target population: Persons aged 65 years and older
Purpose: Listing on National Immunisation Program (NIP)
Comparative analysis: Cost-minimisation versus standard quadrivalent influenza vaccine (QIV)
Advisory review: PBAC and ATAGI evaluation
Implementation considerations: Cold chain capacity, provider communication, monitoring adverse events
Destination Vaccination [Retailer Name] − Adults, the Flu, and Quadrivalent Influenza Vaccine
Year: 2014-2015
Region / City: United States
Topic: Influenza Vaccination
Document Type: Informational Guide
Organization / Institution: Centers for Disease Control and Prevention (CDC)
Author: [xxx]
Target Audience: Pharmacists, Healthcare Providers, Retailers
Period of Validity: Current influenza season
Approval Date: Not specified
Modification Date: Not specified
INFLUENZA QUADRIVALENT ADJUVANTED VACCINE, Injection 0.5 mL Fluad® Quad, and INFLUENZA TRIVALENT ADJUVANTED VACCINE, Injection 0.5 mL, Fluad®, Seqirus (Australia) Pty Ltd
Year: 2019
Region / City: Australia
Topic: Influenza Vaccination
Document Type: Application for Immunization Program Listing
Organization / Institution: Seqirus (Australia) Pty Ltd
Author: Seqirus (Australia) Pty Ltd
Target Audience: Health policymakers, healthcare providers
Period of Validity: Ongoing
Approval Date: 2019
Amendment Date: N/A
Grippol® Quadrivalent Patient Information Leaflet
Year: 2026
Region / City: Russian Federation
Type: Patient information leaflet
Product: Grippol® Quadrivalent
Therapeutic group: Vaccine against influenza (inactivated) with adjuvant
Dosage form: Solution for intramuscular and subcutaneous injection
Active ingredients: Influenza virus antigens A(H1N1), A(H3N2), B Yamagata, B Victoria, Azoximer bromide
Indications: Influenza prophylaxis for children over 6 years, adolescents, adults under 60 years, high-risk and occupational groups
Contraindications: Allergy to chicken proteins or vaccine components, age under 6, pregnancy (for preservative-containing vaccine), acute illness
Administration: Intramuscular or deep subcutaneous injection, 0.5 ml per dose, annual vaccination
Storage conditions: 2–8 °C, protect from contamination, follow aseptic rules
Regulatory status: Marketing authorization in Russia
Topics: Afluria 05mL Quadrivalent