Summary of Product Characteristics
last updated on the eMC:
22/02/2012
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 22/02/2012 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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| Date of revision of text on the SPC: 01-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to Marketing authorisation holder and marketing authorisation number.
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Updated on 06/03/2008 and displayed until 22/02/2012
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/06/2007 and displayed until 06/03/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 10 Date of revision
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Updated on 24/01/2007 and displayed until 25/06/2007
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 – Change the name of the active substance from Ethinyloestradiol to Ethinylestradiol
Section 5.2 – Change the name of the active substance from Ethinyloestradiol to Ethinylestradiol
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Updated on 14/08/2002 and displayed until 24/01/2007
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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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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/03/2002 and displayed until 14/08/2002
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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 (partial) revision of the text
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Updated on 20/08/2001 and displayed until 04/03/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/07/2001 and displayed until 20/08/2001
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 13/09/2000 and displayed until 27/07/2001
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Reasons for adding or updating:
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Updated on 28/01/2000 and displayed until 13/09/2000
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 28/01/2000
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Reasons for adding or updating:
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