Summary of Product Characteristics
last updated on the eMC:
22/07/2010
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 22/07/2010 and displayed until Current
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - addition of sucrose warning.
Section 10 - date of revision amended.
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Updated on 29/07/2009 and displayed until 22/07/2010
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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 4.4 - Special warnings and precautions for Use
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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-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - name amended to include full pharamceutical form
Section 4.4 - lactose warning deleted - error in previous version
Section 10 - date of revision amended
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Updated on 27/04/2009 and displayed until 29/07/2009
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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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| Date of revision of text on the SPC: 18-Jun-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - CP Pharmaceuticals amended to Wockhardt UK Limited
Section 8 - PL 04543/0431 to PL 29831/0053
Section 9 - Date of first authorisation amended
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Updated on 13/05/2003 and displayed until 27/04/2009
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 04/09/2002 and displayed until 13/05/2003
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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