Summary of Product Characteristics
last updated on the eMC:
03/09/2009
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 03/09/2009 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: 13-Nov-2008 |
| 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 24/11/2008 and displayed until 03/09/2009
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 13-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| - section 4.4 – co-administration with vaccines
- section 4.8 - Reported reactions arranged according to MedDRA System Organ System
- section 5.1 – addition of ATC code
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Updated on 26/08/2008 and displayed until 24/11/2008
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 14-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section3. Pharmaceutical Form – addition of ‘White, hard’, gelatine capsules.
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Updated on 26/06/2008 and displayed until 26/08/2008
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Reasons for adding or updating:
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Change of inactive ingredient
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| Date of revision of text on the SPC: 01-Jun-2008 |
| 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 07/08/2007 and displayed until 26/06/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 – Change in the name of polyoestradiol (Ban) to polyestradiol (INN)
Section 10 – Change in the date of revision
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Updated on 18/07/2007 and displayed until 07/08/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7.0 – Marketing Authorisation Holder
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Updated on 03/06/2004 and displayed until 18/07/2007
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 23/04/2003 and displayed until 03/06/2004
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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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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 10/07/2002 and displayed until 23/04/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 04/07/2002 and displayed until 10/07/2002
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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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Updated on 04/03/2002 and displayed until 04/07/2002
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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 10/07/2001 and displayed until 20/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 10/07/2001
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Reasons for adding or updating:
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