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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: 09/03/2012
SPC Epanutin Ready Mixed Parenteral

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 09/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   29-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SPC has been updated.
Updated on 01/06/2010 and displayed until 09/03/2012
Reasons for adding or updating:
  • 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:   25-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SmPC: Section 4.4 (Special Warnings): W

ording update for phenytoin-related Stevens Johnson Syndrome (SJS) and association with HLA-B*1502.

ording update for phenytoin-related Stevens Johnson Syndrome (SJS) and association with HLA-B*1502.
Updated on 01/12/2008 and displayed until 01/06/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   18-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of class warning for anti-epileptics regarding suicidal ideation and behaviour.
Updated on 28/04/2008 and displayed until 01/12/2008
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


6.3 Reduction in Shelf Life from 36 months to 30 months
Updated on 06/03/2008 and displayed until 28/04/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/09/2007 and displayed until 06/03/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10 - Change to date of revision and change to version code.
Updated on 11/07/2006 and displayed until 19/09/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 2 - qualitative and quantitative composition
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Reason for Submission: Change to section 3 - pharmaceutical form, Change to section 2 - qualitative and quantitative composition
Updated on 06/07/2006 and displayed until 11/07/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
Date of revision of text on the SPC:   07/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2.  changed from 'Phenytoin sodium 250mg/5ml (50mg/ml)  to 250 mg (50mg/ml).
 
Section 3. changed from 'Clear, colourless, sterile solution for injection to 'Clear, colourless, sterile solution'
Updated on 17/05/2006 and displayed until 06/07/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/05/2006 and displayed until 17/05/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Pending awaiting re-submission
Updated on 13/12/2005 and displayed until 09/05/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 06/12/2005 and displayed until 13/12/2005
Reasons for adding or updating:
  • No reasons supplied
Updated on 30/03/2005 and displayed until 06/12/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 23/03/2004 and displayed until 30/03/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  phenytoin sodium