Summary of Product Characteristics
last updated on the eMC:
14/10/2009
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 14/10/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5 - Pharmacological Properties
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Change to section 6.2 - Incompatibilities
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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-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to the following sections:
1: addition of 'prolonged release tablets' to the name of the medicinal product
2: lactose monohydrate content added
4.4: addition of paragraph relating to lactose
4.5: interaction of tramadol with ondansetron
4.8: revised Undesirable Effect table
4.9: addition of outcome of tramadol overdose
5: Pharmacotherapeutic group added
6.2: 'Not applicable' added
10: Date of revision of the SPC text
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Updated on 02/09/2008 and displayed until 14/10/2009
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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-Aug-2006 |
| 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 22/09/2005 and displayed until 02/09/2008
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Reasons for adding or updating:
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New SPC for new product
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SPC Retired pending re-submission
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