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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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: 16/03/2012
SPC Fluarix

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 16/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.1 Clarify indication age range
4.2 Clarify dosing recommendation
4.3 Clarify existing statement
4.4 Addition of syncope warning
4.6 Updated in line with core influenza SmPC wording on use in pregnancy
4.7 Clarification on wording in line with core influenza SmPC
4.8 Minor corrections
6.4 Minor amendment
6.6 Additional wording to clarify instructions for use, in particular use of 0.25ml dose in children aged 6 months -35 months
10 Updated with new date of revision of text
Updated on 01/11/2011 and displayed until 16/03/2012
Reasons for adding or updating:
  • Transferred from eMC version 1
Date of revision of text on the SPC:   23-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated description
Updated on 25/05/2011 and displayed until 01/11/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
10.  Revision date

The 2011/2012 strain has not changed from 2010/2011 strain.
Updated on 10/08/2010 and displayed until 25/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2:    Annual strain 2010/2011.    This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2010/2011 season.

Section 4.3  Hypersensitivity to the active substances, to any of the excipients and to residues e.g. eggs, chicken proteins, such as ovalbumin. The vaccine may contain residues of the following substances, e.g. formaldehyde, gentamicin sulphate and sodium deoxycholate.


Section 6.6.  Instructions on administering and disposal.

Updated on 21/09/2009 and displayed until 10/08/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Fluarix, suspension for injection in a pre-filled syringe
Influenza vaccine (split virion, inactivated)

Section 2 -Split Influenza virus, inactivated, containing antigens* equivalent to:
A/Brisbane/59/2007 (H1N1)-like strain:
A/Brisbane/59/2007 (IVR-148) 15 micrograms HA**
A/Brisbane/10/2007 (H3N2)-like strain:
A/Uruguay/716/2007 (NYMC X-175C) 15 micrograms HA**
B/Brisbane/60/2008-like strain:
B/Brisbane/60/2008 15 micrograms HA**
per 0.5 ml dose
* propagated in fertilized hens' eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2009/2010 season.

For a full list of excipients see section 6.1.

Section 9 - Date of first authorization: 27 February 1998
Renewal of the authorization: 30 December 2002

Section 10 -07/08/2009
Updated on 15/07/2009 and displayed until 21/09/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - Contraindications
Hypersensitivity to the active substances, to any of the excipients, to residues, to egg and to chicken protein. Fluarix does not contain more than 0.05 microgram ovalbumin per dose. The vaccine may contain residues of the following substances, e.g. formaldehyde, gentamicin sulphate and sodium deoxycholate.

 

Immunisation shall be postponed in patients with febrile illness or acute infection.

 

Section 10 - 01/07/2009

 
Updated on 02/09/2008 and displayed until 15/07/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - New influenza strains to comply with WHO recommendation (northern hemisphere) and EU decision for 2008/2009 season

Section 4.2 - Clarification of the age limit<9 years of children that require a second dose

Section 4.3 - Removal of thiomersal as a possible residue

Section 4.4 - Removal of thiomersal use during the manufacturing process

Section 10 - Approval date: 20/08/2008
Updated on 24/08/2007 and displayed until 02/09/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: To harmonise the Fluarix SPC across Europe and to include the strain change for 2007/2008 season
 
Formatting changes to all sections
Updated on 09/05/2007 and displayed until 24/08/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: Reformatted for comprehension and compatibility for display on eMC
Updated on 09/05/2007 and displayed until 09/05/2007
Reasons for adding or updating:
  • Change due to harmonisation of SPC
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to whole SPC due to harmonisation.
Section 10: Updated date of revision
Updated on 22/09/2006 and displayed until 09/05/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
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

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 21/09/2006 and displayed until 22/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 4.3 - Contra-indications
  • Change to section 2 - qualitative and quantitative composition
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 31/08/2005 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 01/09/2004 and displayed until 31/08/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 26/04/2004 and displayed until 01/09/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 29/03/2004 and displayed until 26/04/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 3 - pharmaceutical form
Updated on 23/07/2003 and displayed until 29/03/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 29/07/2002 and displayed until 23/07/2003
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 12/02/2002 and displayed until 29/07/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
Updated on 15/08/2001 and displayed until 12/02/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 01/09/2000 and displayed until 15/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 01/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  influenza vaccine (split virion, inactivated)