Summary of Product Characteristics
last updated on the eMC:
27/01/2012
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 27/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 - Reduction in shelf life from 5 to 3 years.
Section 10 - Date of revision of text amended from April 2010 to December 2011.
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Updated on 20/04/2011 and displayed until 27/01/2012
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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: 06-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.4 (special precautions for storage), the following information has been added:
This medicinal product does not require any special temperature storage conditions. Store in the original package. Keep the blisters or bottles in the outer carton in order to protect from light.
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Updated on 22/05/2006 and displayed until 20/04/2011
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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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| Date of revision of text on the SPC: 31/12/05 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1, List of excipients - polyvidone amended to povidone
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Updated on 17/08/2001 and displayed until 22/05/2006
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Reasons for adding or updating:
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Change from datasheet to SPC
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