Summary of Product Characteristics
last updated on the eMC:
27/01/2010
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 27/01/2010 and displayed until Current
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 04-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Renewal date is 4/1/09. Both sections updated to reflect this date.
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Updated on 17/09/2009 and displayed until 27/01/2010
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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 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 30-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes are as follows:
2. Qualitative and quantitative composition
Addition of excipients to comply with QRD template
4.4. Special warnings and special precautions for use
Added comment on systemic effects of corticosteroids
4.8. Undesirable Effects
Updated section on Psychiatric disorders to add “In addition very rarely a wide range of psychatric/behavioural effects may occur”
6.1. List of excipients
Added capsule shell ingredients
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Updated on 09/08/2007 and displayed until 17/09/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Replacement of the excipient dibutyl phthalate with triethyl citrate.
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Updated on 13/09/2006 and displayed until 09/08/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 30/09/2005 and displayed until 13/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 29/09/2005 and displayed until 30/09/2005
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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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