OPTAFLU

Main information

  • Trade name:
  • OPTAFLU inactivated influenza virus vaccine (surface antigens), prepared in cell cultures injection pre-filled syringe (with nee
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OPTAFLU inactivated influenza virus vaccine (surface antigens), prepared in cell cultures injection pre-filled syringe (with nee
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220737
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220737

OPTAFLU inactivated influenza virus vaccine (surface antigens), prepared in cell cultures injection pre-filled

syringe (with needle)

ARTG entry for

Medicine Registered

Sponsor

Seqirus Pty Ltd

Postal Address

63 Poplar Road,PARKVILLE, VIC, 3052

Australia

ARTG Start Date

13/03/2015

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. OPTAFLU inactivated influenza virus vaccine (surface antigens), prepared in cell cultures injection

pre-filled syringe (with needle)

Product Type

Single Medicine Product

Effective date

27/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the prevention of influenza caused by Influenza Virus, Types A and B in adults over 18 years of age.For full details regarding the recommendations

for influenza vaccination refer to the current Australian Immunisation Handbook

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

Neither child resistant

closure nor restricted

flow insert

Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 prefilled syringe per pack

(S4) Prescription Only Medicine

Components

1. OPTAFLU inactivated influenza virus vaccine (surface antigens), prepared in cell cultures injection pre-filled syringe (with needle)

Dosage Form

Injection, suspension

Route of Administration

Intramuscular

Visual Identification

Clear to slightly opalescent liquid for injection

Active Ingredients

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 26.11.2017 at 02:10:57 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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