Summary of Product Characteristics
last updated on the eMC:
28/02/2012
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 28/02/2012 and displayed until Current
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 01-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of Black Triangle
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Updated on 20/09/2010 and displayed until 28/02/2012
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of MA holder to:
SpePharm Holding B.V.
Kingsfordweg 151
NL – 1043 GR Amsterdam
Netherlands
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Updated on 17/03/2010 and displayed until 20/09/2010
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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: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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