Summary of Product Characteristics
last updated on the eMC:
18/11/2010
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 18/11/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 03-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| In section 6.5 Nature and contents of container - text for 5 and 25 vials has been added as follows:
Pack sizes of 1, 5 and 25 vials.
Not all pack sizes may be marketed.
In section 8 Marketing Authorisation Number(s), the following have been added:
EU/1/10/646/005
EU/1/10/646/006
In section 10 Date of Revision of the text - 03/11/2010 has been added.
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Updated on 04/11/2010 and displayed until 18/11/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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