Summary of Product Characteristics
last updated on the eMC:
27/04/2012
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 27/04/2012 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 8 - MARKETING AUTHORISATION NUMBER(S)
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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-Apr-2012 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 7 & 8 updated to reflect change in MAH to Forest Laboratories UK Ltd
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Updated on 18/03/2009 and displayed until 27/04/2012
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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. 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: 17-Sep-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 2 (Qualitative and Quantative Composition) - changed from 0.075% w/w to 0.15mg
In section 6.3 (Shelf life) changed from 60 months to 3 years
In section 10 (Date of Revision of the Text) - changed to 17/09/2008
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Updated on 21/06/2007 and displayed until 18/03/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/06/2007 and displayed until 21/06/2007
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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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