Summary of Product Characteristics
last updated on the eMC:
16/01/2012
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 16/01/2012 and displayed until Current
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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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| Date of revision of text on the SPC: 10-Jan-2012 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Acute Porphyria warning was included in this section
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Updated on 19/10/2011 and displayed until 16/01/2012
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 31-Aug-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| to include additional contraindication - paralytic ileus
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Updated on 02/08/2010 and displayed until 19/10/2011
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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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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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| Date of revision of text on the SPC: 04-Dec-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Special Warnings and Precautions for Use: Change to amount of potassium contained per sachet.
Section 4.8 - Undesirable Effects: More effects added
Section 6.1 - List of Excipients: Extra excipient added
Section 6.4 - Special Precautions for Storage: wording altered. |
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Updated on 31/05/2006 and displayed until 02/08/2010
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 01/11/05 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 10: The date of revision of the text has changed.
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Updated on 27/09/2004 and displayed until 31/05/2006
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Reasons for adding or updating:
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SPC Retired pending re-submission
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Improved Electronic Presentation
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Updated on 29/09/2003 and displayed until 27/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 01/10/2002 and displayed until 29/09/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 28/08/2001 and displayed until 01/10/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/08/2001 and displayed until 28/08/2001
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Reasons for adding or updating:
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Change to separate SPCs covering individual presentations
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Updated on 21/08/2001 and displayed until 23/08/2001
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 06/09/1999 and displayed until 21/08/2001
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Reasons for adding or updating:
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