H-C-832  
Pandemrix Exceptional circumstances - Click for more information
European Public Assessment Report
Revision 4 - Published 16/11/09

Glossary

BG = bălgarski
ES = español
CS = čeština
DA = dansk
DE = Deutsch
ET = eesti keel
EL = elliniká
EN = English
FR = français
IT = italiano
LV = latviešu valoda
LT = lietuvių kalba
HU = magyar
MT = Malti
NL = Nederlands
PL = polski
PT = português
RO = română
SK = slovenčina
SL = slovenščina
FI = suomi
SV = svenska

 
Additional information
Press Release - 25/09/09
Questions and Answers - 25/09/09
 
BG ES CS DA DE ET EL EN FR IT LV LT HU MT NL PL PT RO SK SL FI SV   See Glossary of language codes...
u u u u u u u u u u u u u u u u u u u u u u   Summary for the public
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u u u u u u u u u u u u u u u u u u u u u u   All Authorised Presentations
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              u                               Public assessment report (6)*
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              u                               Procedural steps taken and scientific information after authorisation (8)
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* This vaccine was initially developed as a pandemic mock-up vaccine using an H5N1 strain. The public assessment report for the mock-up H5N1 vaccine can be found here.
   
   
Product Information*  
11/11/2009 Pandemrix-H-C-832-II-19  
BG ES CS DA DE ET EL EN FR IT LV LT HU MT NL PL PT RO SK SL FI SV   See Glossary of language codes...
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u u u u u u u u u u u u u u u u u u u u u u  
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(*)This document includes:

Annex I - Summary of product Characteristics
Annex IIA - Manufacturing Authorisation Holder responsible for Batch Release
Annex IIB - Conditions of the Marketing Authorisation (including specific obligations for products under conditional approval or exceptional circumstances)
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.
   
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EPARs for authorised medicinal products for human use