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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: 20/08/2010
SPC Salazopyrin Tablets

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 20/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   17-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC
Section 7
Pfizer Limited stated as MA Holder

Section 8
Marketing Authorisation number updated in line with change

Section 9
New date of Authorisation added
Updated on 13/10/2009 and displayed until 20/08/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   18-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 has been updated to include DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), hepatic failure, fulminant hepatitis, diarrhoea, vomiting and interstitial lung disease as Adverse Events and assign frequencies to existing ones.
Updated on 11/08/2009 and displayed until 13/10/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   14-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Updated section 4.4 to include warnings on use in children with juvenile rheumatoid arthritis and advice on adequate fluid intake.

 Please note that section 4.8 are also being updated, the changes made to the patient information leaflet will be made when all variations are approved.
Updated on 29/05/2009 and displayed until 11/08/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   19-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3: Updated to include contra-indication for metabolites of Sulfasalazine and its excipients.

Section 4.5: Interactions added for azathioprine and methotrexate.

Section 4.6: Statement added that as possibility of harm cannot be ruled out Salazopyrin should only be used if needed.
Updated on 11/03/2008 and displayed until 29/05/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/03/2008 and displayed until 11/03/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/09/2006 and displayed until 06/03/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 13/07/2006 and displayed until 28/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
MAH changed from Pharmacia, Milton Keynes to Pharmacia ,Sandwich.
Updated on 17/08/2005 and displayed until 13/07/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 15/08/2005 and displayed until 17/08/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 14/06/2005 and displayed until 15/08/2005
Reasons for adding or updating:
  • Change from BAN to rINN
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 15/04/2003 and displayed until 14/06/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/04/2003 and displayed until 15/04/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/07/2002 and displayed until 10/04/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/04/2002 and displayed until 26/07/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/04/2002 and displayed until 12/04/2002
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/07/2001 and displayed until 08/04/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 23/08/2000 and displayed until 27/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  sulfasalazine