Summary of Product Characteristics
last updated on the eMC:
27/09/2011
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 27/09/2011 and displayed until Current
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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 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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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 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 14-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SmPC has been updated in line with the Company Core Safety Information.
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Updated on 27/08/2009 and displayed until 27/09/2011
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Reasons for adding or updating:
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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 4.7 - 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 4.9 - Overdose
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| Date of revision of text on the SPC: 30-Sep-2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 - deleted 'and in those persons with hypersensitivity to any component of this preparation'
Section 4.4 - reference to contact lenses added and reference to steroids and BAK removed
Section 4.7 - deleted ' Unknown. Transient, blurred vision may occur immediately after administration. Do not drive or operate machinery if affected.'
Section 4.8 - whole section amended to Medra terminology
Section 4.9 - deleted 'A topical overdosage of Vexol may be flushed from the eye(s) with luke warm tap water.'
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Updated on 15/11/2002 and displayed until 27/08/2009
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Removal of Black Triangle
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Updated on 17/08/2001 and displayed until 15/11/2002
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Addition of Black Triangle
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Updated on 13/07/2001 and displayed until 17/08/2001
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Transferred from eMC version 1
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Updated on 22/06/2001 and displayed until 13/07/2001
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Updated on 06/04/2001 and displayed until 22/06/2001
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