Summary of Product Characteristics
last updated on the eMC:
06/11/2009
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 06/11/2009 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 6. 6 - Instructions for use, handling and disposal
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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: 29-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The key changes to the SmPC are:
Section 2 (Qualitative and quantitative composition), lactose and sucrose content and a reference to see Section 6.1 for the full list of excipients.
Section 6.6 (Special precautions for disposal) has been changed to 'No special requirements'.
Section 10 (Date of revision of the text) has been updated.
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Updated on 19/05/2008 and displayed until 06/11/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The Marketing Authorisation Holder has changed from Schering Health Care Limited to Bayer plc.
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Updated on 25/02/2005 and displayed until 19/05/2008
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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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Change from the BAN of the active substance to the rINN
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Updated on 08/01/2002 and displayed until 25/02/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 16/08/2001 and displayed until 08/01/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 19/07/2001 and displayed until 16/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 30/08/2000 and displayed until 19/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 30/08/2000
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Reasons for adding or updating:
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