Summary of Product Characteristics
last updated on the eMC:
17/11/2011
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 17/11/2011 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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| Date of revision of text on the SPC: 09-Jul-2010 |
| 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 sodium warning.
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Updated on 01/09/2008 and displayed until 17/11/2011
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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 9 - Date of first Authorisation/renewal of the Authorisation
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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-Jan-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - name updated to include full pharmaceutical fomr
Section 7 - MA holder amended from 'CP Pharmaceuticals Ltd' to 'Wockhardt UK Ltd'
Section 8 - PL number amended from PL 04543/0391 to PL 29831/0076
Section 9 - Date of first authorisation amended
Section 10 - Date of revision amended
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Updated on 20/09/2006 and displayed until 01/09/2008
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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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