Summary of Product Characteristics
last updated on the eMC:
02/09/2010
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 02/09/2010 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 15-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 7. MARKETING AUTHORISATION HOLDER
Warner Chilcott UK Limited
Old Belfast Road
Millbrook, Larne
County Antrim
BT40 2SH
United Kingdom
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Updated on 04/11/2008 and displayed until 02/09/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 16-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Updated section 6.3:
3 years
Updated section 10:
16/09/2008
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Updated on 22/09/2008 and displayed until 04/11/2008
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 18-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 1:
Black triangle was accidently removed, this update is to physically add the black triangle to SPC
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Updated on 08/09/2008 and displayed until 22/09/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8 (undesirable effects), abdominal pain has been added
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Updated on 29/03/2007 and displayed until 08/09/2008
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Added black triangle to section 1
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Updated on 26/03/2007 and displayed until 29/03/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 26/03/2007 and displayed until 26/03/2007
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Reasons for adding or updating:
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