Summary of Product Characteristics
last updated on the eMC:
11/10/2011
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 11/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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: 07-Oct-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.2 has been changed on the 07/10/2011 to include “babies” in the population allowed to use the product.
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Updated on 02/08/2010 and displayed until 11/10/2011
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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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| Date of revision of text on the SPC: 07-May-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - Nature and Contents of Container - New packaging and pack sizes added, and statement about marketed pack sizes added |
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Updated on 03/09/2007 and displayed until 02/08/2010
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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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