Summary of Product Characteristics
last updated on the eMC:
25/01/2010
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 25/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 20-Jan-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5 'Interaction with other medicinal products and other forms of interaction'.
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Updated on 10/06/2008 and displayed until 25/01/2010
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Reasons for adding or updating:
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SPC Retired pending re-submission
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Change to section 10 date of revision of the text
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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: 01-Apr-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 9: Change to 01 November 1983
Section 10: Change to 01 April 2008
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Updated on 07/04/2008 and displayed until 10/06/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 04/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 Change of MAH from koGEN Limited to Galen Limited.
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Updated on 05/12/2007 and displayed until 07/04/2008
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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: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 the MAH has changed from Provalis Healthcare Limited, Newtech Square, Deeside Industrial Park, Deeside, Flintshire, CH5 2NT to koGEN Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK.
Section 8 the MA number has changed from 14658/0004 to PL 27827/0003.
Section 9 the Date of First Authorisation/Renewal of the Authorisation has changed from 01 September 1998 to 23 October 2006.
Section 10 Date of Revision of the Text has changed from January 04 to 11 December 2006.
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Updated on 11/03/2004 and displayed until 05/12/2007
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 21/08/2001 and displayed until 11/03/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 10/08/2001 and displayed until 21/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 31/07/2001 and displayed until 10/08/2001
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 06/09/1999 and displayed until 31/07/2001
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Reasons for adding or updating:
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