AusPAR: Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B)

Australian Public Assessment Report

AusPAR

AusPAR: Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) [PDF, 1.12 MB]

AusPAR: Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) [Word, 2.03 MB]

Attachment: Product Information: Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) [PDF, 330.59 KB]

Attachment: Product Information: Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) [Word, 167.65 KB]

Attachment: Extract from Clinical Evaluation Report: Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) [PDF, 2.61 MB]

Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) [Word, 3.53 MB]

Device/Product Name

Optaflu

Active ingredients

Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B)

AusPAR Date

24 August 2015

Published

15 September 2015

Submission Number

PM-2013-04969-1-2

Submission Type

New chemical entity

Decision

Approved