Summary of Product Characteristics
last updated on the eMC:
22/10/2009
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 22/10/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 29-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| sec. 4.2 - The recommanded dosage for Maintenance treatment has changed to "2g mesalazine once daily".
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Updated on 18/02/2005 and displayed until 22/10/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 22/09/2004 and displayed until 18/02/2005
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Reasons for adding or updating:
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Updated on 26/09/2003 and displayed until 22/09/2004
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/11/2002 and displayed until 26/09/2003
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 17/08/2001 and displayed until 04/11/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 17/01/2001 and displayed until 17/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 17/01/2001
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Reasons for adding or updating:
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