Focetria

influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted)

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The marketing authorisation for Focetria has been expired following the marketing-authorisation holder's decision not to apply for a renewal.

Name Language First published Last updated
Focetria : EPAR - Summary for the public BG = bălgarski 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public ES = español 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public CS = čeština 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public DA = dansk 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public DE = Deutsch 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public ET = eesti keel 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public EL = elliniká 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public EN = English 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public FR = français 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public IT = italiano 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public LV = latviešu valoda 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public LT = lietuvių kalba 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public HU = magyar 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public MT = Malti 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public NL = Nederlands 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public PL = polski 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public PT = português 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public RO = română 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public SK = slovenčina 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public SL = slovenščina 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public FI = suomi 2009-12-04 2010-10-05
Focetria : EPAR - Summary for the public SV = svenska 2009-12-04 2010-10-05

This EPAR was last updated on 11/02/2016 .

Authorisation details

Product details

Product details for Focetria
NameFocetria
Agency product numberEMEA/H/C/000710
Active substance

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181 7.5 microgragms per 0.5 ml dose

International non-proprietary name (INN) or common name

influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted)

Therapeutic area Influenza, HumanImmunizationDisease Outbreaks
Anatomical therapeutic chemical (ATC) code J07BB02

Publication details

Publication details for Focetria
Marketing-authorisation holder

Novartis Vaccines and Diagnostics S.r.l.

Revision9
Date of issue of marketing authorisation valid throughout the European Union02/05/2007

Contact address:

Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina 1
IT-53100 Siena
Italy

Product information

Product information

15/01/2015  Focetria -EMEA/H/C/000710 -PSUV/0033

Name Language First published Last updated
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13
Focetria : EPAR - Product Information SV = svenska 2009-12-04 2015-02-13

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.


Name Language First published Last updated
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  
Focetria : EPAR - All Authorised presentations SV = svenska 2009-11-16  

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Prophylaxis of influenza caused by A (H1N1v) 2009 virus.

Focetria should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Focetria : EPAR - Assessment Report SV = svenska 2009-10-01  
Focetria : EPAR - Procedural steps taken before authorisation SV = svenska 2007-05-07  
Focetria : EPAR - Scientific Discussion SV = svenska 2007-05-07  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Focetria