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Novartis Vaccines

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Telephone: +44 (0)1276 694 490
Fax: +44 (0)1276 698 460
WWW: http://www.novartis.com
Medical Information Direct Line: +44 (0)8457 451 500
Medical Information e-mail: service.uk@novartis.com
Medical Information Fax: +44 (0)1517 055 669

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 19/09/2011
SPC Agrippal Influenza vaccine (surface antigen, inactivated)

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 19/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 10. DATE OF REVISION OF TEXT

 

05/2011

Updated on 02/09/2010 and displayed until 19/09/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
  • SPC Retired pending re-submission
  • Retired by Pharmaceutical Company
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
- in section 2.0, viral strains for 2010-2011 season updated
- in section 10, date of revision of text updated
Updated on 07/09/2009 and displayed until 02/09/2010
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
= section 2 includes a revision to reflect 2009/2010 strains for seasonal flu vaccination
- section 10 inlcudes a date of revision of the text to June 2009
Updated on 22/08/2008 and displayed until 07/09/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
- In section 2 (qualitative and quantitative composition) the influenza virus sarface antigens have been updated for the 2008/2009 season
- In section 10 (date of revision of the text), the date has been updated to incorporate the new 2008/2009 antigen strains
Updated on 05/11/2007 and displayed until 22/08/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - updated new season to (2007/2008 season)
Section 2 - updated new composition of viral strains
Updated on 18/09/2006 and displayed until 05/11/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
NAME OF THE MEDICINAL PRODUCT 
(2005/2006 season) has changed to (2006/2007 season).
 
 
QUALITATIVE AND QUANTITATIVE OOMPOSITION

A/California/7/2004 (H3N2) – like strain (A/New York/55/2004 NYMC X-157) changed to

A/Wisconsin/67/2005 (H3N2) – like strain (A/Hiroshima/52/2005 IVR 142)

B/Shanghai/361/2002 - like strain (B/Jiangsu/10/2003) changed to
B/Malaysia/2506/2004 – like strain (B/Malaysia/2506/2004)
 
This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2005/2006 season
changed to This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2006/2007 season.
 
 
 

 

 
 
Updated on 27/09/2005 and displayed until 18/09/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/09/2004 and displayed until 27/09/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 04/08/2003 and displayed until 24/09/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/09/2002 and displayed until 04/08/2003
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/08/2002 and displayed until 10/09/2002
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/10/2001 and displayed until 30/08/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  influenza vaccine (surface antigen, inactivated)