Summary of Product Characteristics
last updated on the eMC:
28/10/2011
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 28/10/2011 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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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 27-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 2 (Qualitative and Quantitive Composition) the following text has been added regarding excipients has been added:
'Excipients:
Cetostearly Alcohol
For a full list of excipients see 6.1.'
In Section 4.4 (Special warnings and precautions for use) the following excipient warning has been added:
'This product contains Cetostearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis)'
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Updated on 26/07/2010 and displayed until 28/10/2011
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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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| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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