EMEA-000725-PIP01-09-M03

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Overview

Product details for Pandemrix
Invented namePandemrix
Active substance

Split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)

Decision numberP228/2011
PIP numberEMEA-000725-PIP01-09-M03
Pharmaceutical form(s)Suspension and emulsion for injection
Condition(s)/indication(s)

Influenza

Route(s) of administrationIntramuscular use
PIP applicant

GlaxoSmithKline Biologicals S.A.
E-mail: rix.eudralink@gskbio.com
Country: Belgium
Phone: +32 10859472
Fax: +32 10858194

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-000725-PIP01-09-M03
Compliance check opinion date12/12/2014
Compliance check outcomePositive

Decision

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