Summary of Product Characteristics
last updated on the eMC:
18/01/2010
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 18/01/2010 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 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-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Amendment to sections 7. 8. and 10 following change of ownership approval
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Updated on 02/09/2008 and displayed until 18/01/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| 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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| Change to Section 7. Marketing Authorisation Holder - change of address.
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Updated on 02/11/2006 and displayed until 02/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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SPC Retired pending re-submission
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - change of Marketing Authorisation holder
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Updated on 24/03/2003 and displayed until 02/11/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 21/03/2003 and displayed until 24/03/2003
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 31/05/2002 and displayed until 21/03/2003
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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 - MA number
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