Summary of Product Characteristics
last updated on the eMC:
21/09/2011
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 21/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1- To change the specifications of the excipients yellow soft paraffin and menthol to EP
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Updated on 28/10/2009 and displayed until 21/09/2011
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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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 01-Apr-2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Deregulation of wool fat, paraffins and starch to excipient status:
In Section 2 (qualitative and quantitative composition), wool fat Ph. Eur., yellow soft paraffin B. P., white soft paraffin B. P., light liquid paraffin Ph. Eur. and starch Ph removed and entered in Section 6.1 (list of excipients).
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Updated on 16/02/2005 and displayed until 28/10/2009
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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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Updated on 07/08/2001 and displayed until 16/02/2005
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 15/03/2001 and displayed until 07/08/2001
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Reasons for adding or updating:
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