Summary of Product Characteristics
last updated on the eMC:
13/01/2010
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 13/01/2010 and displayed until Current
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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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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 22-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 - Reference to tobramycin and aminoglycosides added
Section 4.4 - Reference to sensitivity to topical administration added
Section 4.8 - Section updated to Medra terminology
Section 4.9 - Reference to overdose is unlikely due to limited capacity of conjunctival sac deleted.
Section 5.1 - Reference to tobramycin potency and its actions has been deleted.
Section 10 - Date changed to 22 October 2009
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Updated on 15/10/2008 and displayed until 13/01/2010
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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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| Date of revision of text on the SPC: |
| 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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