Summary of Product Characteristics
last updated on the eMC:
07/09/2011
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 07/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 07-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes made from previous: updated Section 3 of the SmPC to reflect removal of tablet engraving - removal of "A" embossed on one side of tablet
Previously
Pharmaceutical Form
Preservex film-coated tablets 100 mg are presented as white round film-coated tablets, 8 mm in diameter, with an "A" embossed on one side.
Now
Pharmaceutical Form
Preservex film-coated tablets 100 mg are presented as white round film-coated tablets, 8 mm in diameter.
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Updated on 16/03/2011 and displayed until 07/09/2011
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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: 26-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 of SmPC updated to change the MAH from "Laboratorios Almirall SA" to "Almirall SA".
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Updated on 02/07/2009 and displayed until 16/03/2011
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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: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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