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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 04/08/2011
SPC Enzira Suspension for injection, pre-filled syringe/Influenza vaccine (split virion, inactivated) PH. Eur.

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 04/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   15-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: Re-wording of strain information.
Section 10: date of revision updated.
Updated on 23/06/2011 and displayed until 04/08/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   27-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Additional safety wording in section 4.4 of the SmPC regarding an increase in reports of fever in 5-9 year olds, and updated the wording on the restricted use of the product in children less than 5 years of age.
Updated on 20/08/2010 and displayed until 23/06/2011
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 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC

Section 2

Flu strains and season updated



Section 4.2

Update to posology age groups



Section 4.4

Added text regarding use in children under 5 years of age



Section 4.8

Addition of febrile convulsions



Section 6.6

Removal of text relating to 0.25 ml dose
Updated on 21/04/2010 and displayed until 20/08/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Shelf life increased to 15 months
Updated on 18/08/2009 and displayed until 21/04/2010
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:   11-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 Vaccine updated to current season.
Updated on 12/09/2008 and displayed until 18/08/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
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
Section 2: Annual Strain Update
Section 10: Date amended
Updated on 10/09/2007 and displayed until 12/09/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  influenza vaccine