Summary of Product Characteristics
last updated on the eMC:
23/12/2010
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 23/12/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Amendments to sections 4.3., 4.4., 4.5. and 10 of the SPC
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Updated on 13/10/2010 and displayed until 23/12/2010
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.4 - deletion of the recommdation that if precipitation of Ancotil occurs, redissolve by heating to 80 deg C for not more than 30 minutes.
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Updated on 12/10/2010 and displayed until 13/10/2010
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 07-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.2
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Updated on 06/08/2009 and displayed until 12/10/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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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Change to Section 7. MAH, Section 9. Date of First Authorisation/Renewal of Authorisation, Section 10.Date of Revision of Text
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Updated on 12/07/2007 and displayed until 06/08/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 01/08/2005 and displayed until 12/07/2007
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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 20/07/2004 and displayed until 01/08/2005
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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 20/07/2004 and displayed until 20/07/2004
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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 19/09/2003 and displayed until 20/07/2004
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 07/08/2001 and displayed until 19/09/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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