Prepandrix

RSS

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Prepandrix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prepandrix.

This EPAR was last updated on 12/12/2017

Authorisation details

Product details
Name
Prepandrix
Agency product number
EMEA/H/C/000822
Active substance
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
International non-proprietary name (INN) or common name
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
13/05/2008
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

27/11/2017 Prepandrix - EMEA/H/C/000822 - R/0071

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against H5N1 subtype of influenza-A virus.

This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.

Prepandrix should be used in accordance with official guidance.

Assessment history

Changes since initial authorisation of medicine

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