|
Fluenz
|
|
Application number
|
EMEA/H/C/001101 |
|
Marketing authorisation holder
|
MedImmune LLC |
|
Name of the product
|
Fluenz |
|
Active substances
|
Influenza virus reassortants |
|
Parental organism
|
Life attenuated strain of Influenza virus |
|
Transgene(s)
|
Influenza virus reassortants for each of the 3 strains selected for the yearly season |
|
Treated organism
|
Humans: children en adolescents |
|
Indication(s)
|
vaccination against influenza A (subtypes H1N1 and H3N2) and influenza B |
|
Administration route(s)
|
nasal spray |
|
Type of authorisation
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Centralised at European level
|
|
Legal frame
|
Council regulation (EC) No 726/2004 (full text in English) and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27 (full text of the Decree in French - in Dutch) |
|
Competent authority
|
EMA/European Commission
|
|
Belgian advisory body
|
Belgian Biosafety Council
|
|
Date of the advice of the Belgian Biosafety Council
|
08/04/2009; 17/06/2010; 13/09/2010 |
|
EMEA (CVMP) opinion
|
positive : abstract
in english (link to Web site of EMA)
|
|
CVMP opinion date
|
27/10/2010 |
|
European Commission authorisation date
|
27/01/2011 |
|
European Commission authorisation number
|
EU/1/10/661 |
|
European Commission decision
|
Community register of medicinal products
|
|
European Public Assessment Report (including Product
information leaflet and Summary of product characteristics
in French, in Dutch or in English)
|
EPAR
(link to Web site of EMA)
|
|
Notifications to Belgian authorities while in Research
and Development stage
|
None
|
