Summary of Product Characteristics
last updated on the eMC:
15/09/2010
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 15/09/2010 and displayed until Current
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 29-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Address change for marketing authorisation holder, Britannia Pharmaceuticals Ltd from Brighton Road to Park View House
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Updated on 04/09/2009 and displayed until 15/09/2010
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 01-May-2009 |
| 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 19/09/2006 and displayed until 04/09/2009
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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: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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There have been changes to the dosage of this medication in the following section:
- Posology and Method of Administration:
The initial dose has been changed from “one 0.2mg tablet twice daily” to “0.8mg per day in divided doses”. The increments per day have changed from “0.2-0.4mg/day” to “0.4 to 0.8mg per day”. The maximum dose remains the same at 2.4mg/day.
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Updated on 04/02/2005 and displayed until 19/09/2006
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 23/09/2004 and displayed until 04/02/2005
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 23/09/2004 and displayed until 23/09/2004
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 23/09/2004 and displayed until 23/09/2004
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 13/06/2003 and displayed until 23/09/2004
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 11/06/2003 and displayed until 13/06/2003
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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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Updated on 24/08/2001 and displayed until 11/06/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 21/08/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Change from datasheet to SPC
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