Summary of Product Characteristics
last updated on the eMC:
06/10/2010
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 06/10/2010 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 09-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 26/07/2010 and displayed until 06/10/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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: 09-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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1. Name of the Medicinal Product
Asacol 250mg and 500mg Suppositories
10. Date of (Partial) Revision of the Text
09 June 2010
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Updated on 18/06/2010 and displayed until 26/07/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
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 Road,
Larne,
County Antrim,
BT40 2SH
8. Marketing Authorisation Number
Asacol Suppositories 250 mg 10947/0013
Asacol Suppositories 500 mg 10947/0014
10. Date of (Partial) Revision of the Text
May 2010
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Updated on 28/01/2003 and displayed until 18/06/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Addition of separate SPCs covering individual presentations
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