Summary of Product Characteristics
last updated on the eMC:
05/06/2008
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 05/06/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 02-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 (MA Holder) has been updated with the 'Bayer Schering Pharma' trading sytle.
Section 10 (Date of Revision of the Text) has been updated with the date of approval of the above.
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Updated on 24/01/2008 and displayed until 05/06/2008
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Submission of an individual SmPC, previously a joint SmPC for 20/30/60.
Global Labelling Harmonization SmPC update (sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3) and update to excipient information (SmPC section 6.1).
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