Summary of Product Characteristics
last updated on the eMC:
01/04/2010
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 01/04/2010 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 approval of change of ownership
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Updated on 13/03/2008 and displayed until 01/04/2010
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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 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: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of MAH
Change fo MA Number
Change of Date of Revision of Text
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Updated on 17/09/2007 and displayed until 13/03/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08/2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.8 Interation with Verapmil added
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Updated on 24/11/2003 and displayed until 17/09/2007
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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 4.4 - Special Warnings and Precautions for Use
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Updated on 07/04/2003 and displayed until 24/11/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 07/04/2003 and displayed until 07/04/2003
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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 12/11/2001 and displayed until 07/04/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 4.8 - Undesirable Effects
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