FLUARIX

Main information

  • Trade name:
  • FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled syringe with needle 2016
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled syringe with needle 2016
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210806
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210806

FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled syringe with

needle

ARTG entry for

Medicine Registered

Sponsor

GlaxoSmithKline Australia Pty Ltd

Postal Address

PO Box 18095,Melbourne, VIC, 8003

Australia

ARTG Start Date

28/08/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled syringe with

needle 2016

Product Type

Single Medicine Product

Effective date

14/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Fluarix Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 3 years of age for the prevention of influenza disease

caused by the influenza virus types A and B contained in the vaccine.,The use of Fluarix Tetra should be based on official recommendations.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

12 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled syringe with needle

Dosage Form

Injection, suspension

Route of Administration

Intramuscular

Visual Identification

1.25 ml glass syringes with Luer lock adapter and plastic rigid tip cap

(PRTC)

Active Ingredients

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 20.10.2017 at 07:10:22 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety