Summary of Product Characteristics
last updated on the eMC:
19/12/2011
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 19/12/2011 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 09-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| typing error corrected - 'tablet' now 'capsule'
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Updated on 19/07/2010 and displayed until 19/12/2011
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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: 09-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| he SPC was revised due to changes in recent renewal (approval October 2008):
The scope of one was to include safety information into the SPC on potential side effects, namely tumour lysis syndrome. The chapter side effects was re-structured and MedDRA requirements were adopted.
The following sections have been changed:
1
2
3
4.2
4.3
4.4
4.5
4.7
4.8 tumour lysis syndrome
4.9
6.2
6.3
6.4
6.6
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Updated on 26/09/2006 and displayed until 19/07/2010
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 22/09/2006 and displayed until 26/09/2006
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Reasons for adding or updating:
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