Summary of Product Characteristics
last updated on the eMC:
04/02/2010
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 04/02/2010 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: 01-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of the following warning to section 4.4. of SPC:
Caution is needed in patients who have a known predisposing factor to cardiac arrhythmia, or who are concomitantly treated with a potentially arrhythmogenic drug. In patients with pre-existing prolonged QT intervals use of alternative treatments is to be considered.
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Updated on 28/02/2006 and displayed until 04/02/2010
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 24/02/2006 and displayed until 28/02/2006
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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 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/02/2006 and displayed until 24/02/2006
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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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