Summary of Product Characteristics
last updated on the eMC:
22/06/2010
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 22/06/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The shelf life of the product has been reduced from 36minths to 24 months.
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Updated on 06/09/2006 and displayed until 22/06/2010
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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 (partial) revision of the text
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| Date of revision of text on the SPC: 02/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
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Updated on 23/11/2004 and displayed until 06/09/2006
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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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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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/09/2003 and displayed until 23/11/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 28/08/2003 and displayed until 17/09/2003
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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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