EMEA-001254-PIP01-11-M02

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Overview

Product details for -
Invented name-
Active substance

Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage) / Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage) / Split influenza virus, inactivated (B/Victoria lineage) / Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain

Decision numberP/0129/2017
PIP numberEMEA-001254-PIP01-11-M02
Pharmaceutical form(s)Suspension for injection
Condition(s)/indication(s)

Prevention of influenza infection

Route(s) of administrationSubcutaneous use; Intramuscular use
PIP applicant

Sanofi Pasteur SP
France
Tel. +33 4373 75038
E-mail: piplan@sanofipasteur.com

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-001254-PIP01-11-M02
Compliance check opinion date23/06/2017
Compliance check outcomePositive

Decision