Summary of Product Characteristics
last updated on the eMC:
27/03/2007
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 27/03/2007 and displayed until Current
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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: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 4.8 - The sentence 'irrespective of the type of agent used' has been removed
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Updated on 26/02/2007 and displayed until 27/03/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 22/02/2007 and displayed until 26/02/2007
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 2, 4.3, 4.4, 4.6, 4.7 and 4.8 updated following a medical safety evaluation and update to the BPI
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Updated on 29/07/2005 and displayed until 22/02/2007
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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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