Summary of Product Characteristics
last updated on the eMC:
02/08/2010
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 02/08/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 02-Jul-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - Qualitative and Quantitative Composition: Rewording and additional ingredient
Section 4.4 - Special warnings and precautions for use: Warning added about lactose presence.
Section 6.3 - Shelf Life: Shelf life for old packaging removed
Section 6.4 - Special Precautions for storage: Storage instructions altered
Section 6.5 - Nature and Contents of Container: One form of packaging removed
Section 9 - Date of first authorisation/Renewal of authorisation: Authorisation renewed |
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Updated on 28/06/2006 and displayed until 02/08/2010
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 08/2004 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10: The date of revision of the text has changed.
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Updated on 27/09/2004 and displayed until 28/06/2006
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Reasons for adding or updating:
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SPC Retired pending re-submission
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Improved Electronic Presentation
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Updated on 29/09/2003 and displayed until 27/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 01/10/2002 and displayed until 29/09/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 21/08/2001 and displayed until 01/10/2002
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Reasons for adding or updating:
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