Summary of Product Characteristics
last updated on the eMC:
22/03/2010
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 22/03/2010 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 7 Marketing Authorisation Holder the address has been amended to:
Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
UK
In section 10 the Date of the Revision of the Text has been updated to:
March 2010
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Updated on 07/07/2009 and displayed until 22/03/2010
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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 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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Change to section 3 - Pharmaceutical form
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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-Mar-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 3
Clear orange/red colourless to pale straw coloured slightly viscous liquid.
Section 6.1
The excipients Ponceau 4R (E124) and Quinoline Yellow (E104) have been removed.
Section 6.3
The shelf life information has been updated to include a shelf life for the new orange coloured PET bottle of 2 years.
Section 6.5
This section has been updated to include an orange coloured PET bottle.
Section 10
The date of revision of the text has been updated to March 2009.
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Updated on 08/09/2008 and displayed until 07/07/2009
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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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Change to section 10 date of revision of the text
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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-Dec-2002 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2
The pharmacopoeial references have been removed.
Section 9
The date of renewal has been updated.
Section 10
The date of last revision has been updated.
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Updated on 20/01/2003 and displayed until 08/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 18/09/2001 and displayed until 20/01/2003
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Reasons for adding or updating:
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Addition of Legal Category
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Updated on 14/08/2001 and displayed until 18/09/2001
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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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