Summary of Product Characteristics
last updated on the eMC:
23/03/2010
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 23/03/2010 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 the Marketing Authorisation Holder address has changed to:
Forest Laboratories UK Ltd
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
UK
In section the Date of the Revision of the text needs to be amended to:
March 2010
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Updated on 08/09/2008 and displayed until 23/03/2010
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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-Dec-2005 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5
An additional pack size has been added:
'Two rolls of 20 tablets in wax laminated foil packed together in a cardboard carton. Pack size: 40'
The wording 'Not all pack sizes may be marketed' has been added.
Section 10
The date of last revision of the text has been updated.
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Updated on 28/09/2004 and displayed until 08/09/2008
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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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