Summary of Product Characteristics
last updated on the eMC:
20/06/2011
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 20/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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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-Jun-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.5 (Nature and contents of container) the text has changed to "10 ml amber glass bottle with plastic cap"
In section 10 (Date of revision of the text) the date has changed to "June 2011"
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Updated on 29/07/2009 and displayed until 20/06/2011
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 01-Apr-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 9 (Renewal of the authorisation) the date has changed to "2 May 2006"
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Updated on 11/09/2007 and displayed until 29/07/2009
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - Nature and contents of container - Addition of text 'This is supplied as an original pack (OP)'
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Updated on 16/08/2007 and displayed until 11/09/2007
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 - Name of the medicinal product: Name has changed from "Salactol" to "Salactol Collodion"
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Updated on 03/08/2004 and displayed until 16/08/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 29/01/2003 and displayed until 03/08/2004
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/09/2002 and displayed until 29/01/2003
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/11/2001 and displayed until 17/09/2002
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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 4.8 - Undesirable Effects
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Updated on 23/07/2001 and displayed until 06/11/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 23/07/2001
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Reasons for adding or updating:
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