Summary of Product Characteristics
last updated on the eMC:
07/03/2011
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 07/03/2011 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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| Date of revision of text on the SPC: 22-Nov-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Reckitt Benckiser (UK) Limited
103-105 Bath Road
Slough, SL1 3UH
United Kingdom
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Updated on 10/09/2010 and displayed until 07/03/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 08-Sep-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The grade of edetic acid has been changed from HSE to EP.
The date of revision of the SmPC has been updated to 08/09/2010
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Updated on 27/07/2010 and displayed until 10/09/2010
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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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| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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