Updated on 23/08/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 12-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 13/10/2009 and displayed until 23/08/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| 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
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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.
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Updated on 11/08/2009 and displayed until 13/10/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 28-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 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.
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Updated on 29/05/2009 and displayed until 11/08/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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| 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
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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.
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Updated on 06/03/2008 and displayed until 29/05/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/09/2007 and displayed until 06/03/2008
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.4 – Wording updated that Suppositories should not be stored above 25°C.
6.6 – Wording updated to “should be kept below 25°C and handled as little as possible”.
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Updated on 18/09/2007 and displayed until 27/09/2007
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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Updated on 15/08/2007 and displayed until 18/09/2007
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.4 – Wording updated that Suppositories should not be stored above 25°C.
6.6 – Wording updated to “should be kept below 25°C and handled as little as possible”.
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Updated on 11/08/2006 and displayed until 15/08/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| 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
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| Change of MAH from Pharmacia Milton Keynes to Pharmacia Sandwich
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Updated on 15/08/2005 and displayed until 11/08/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 10/06/2005 and displayed until 15/08/2005
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Reasons for adding or updating:
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Change from BAN to rINN
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Change to section 4.3 - Contra-indications
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Updated on 05/04/2002 and displayed until 10/06/2005
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 (date of (partial) revision of the text
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Updated on 27/07/2001 and displayed until 05/04/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 23/08/2000 and displayed until 27/07/2001
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Reasons for adding or updating:
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