Summary of Product Characteristics
last updated on the eMC:
30/07/2008
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 30/07/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.8 - Undesirable Effects
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4: Move of some statements to section 4.8
Section 4.8: addition of undesirable effects: Corneal disorders such as superficial punctuate keratitis or edema.
Section 10 : update of revision date
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Updated on 19/09/2007 and displayed until 30/07/2008
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Reasons for adding or updating:
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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: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 10: change in revision of the text
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Updated on 03/10/2005 and displayed until 19/09/2007
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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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