Summary of Product Characteristics
last updated on the eMC:
29/09/2009
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 29/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following items have been added or changed:
4.8 Undesirable Effects
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2Not Known (cannot be estimated from the available data)
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- hallucinations
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Psychiatric
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6.5 Nature and contents of container
PVC/aluminium blisters in carton with 28 or 56 coated tablets per carton.
7 per blister 10 per blister
14 (2 blisters per carton) 20 (2 blisters per carton)
28 (4 blisters per carton) 30 (3 blisters per carton)
56 (8 blisters per carton) 50 (5 blisters per carton)
112 (16 blisters per carton) 60 (6 blisters per carton)
100 (10 blisters per carton)
300 (30 blisters per carton)
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
15 July 2004
21/05/2008
10. DATE OF REVISION OF THE TEXT
August 2008
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Updated on 25/09/2007 and displayed until 29/09/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 28/09/2005 and displayed until 25/09/2007
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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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Updated on 30/09/2004 and displayed until 28/09/2005
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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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