Summary of Product Characteristics
last updated on the eMC:
18/08/2009
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 18/08/2009 and displayed until Current
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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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: 19-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5
Change of text 2nd paragraph to include amiodarone:
Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating effect on atrial-conduction time and induce negative inotropic effect.
Section 4.8
Revised table.
Section 10
Change of revision date to 19 May 2009
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Updated on 21/08/2003 and displayed until 18/08/2009
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Reasons for adding or updating:
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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 05/12/2002 and displayed until 21/08/2003
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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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Updated on 07/11/2002 and displayed until 05/12/2002
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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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Change to section 4.8 - Undesirable Effects
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Updated on 28/11/2001 and displayed until 07/11/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 16/08/2001 and displayed until 28/11/2001
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 06/09/1999 and displayed until 16/08/2001
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Reasons for adding or updating:
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