Summary of Product Characteristics
last updated on the eMC:
13/09/2011
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 13/09/2011 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: 07-Sep-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of, "May cause contact dermatitis," to Section 4.8 Undesirable effects. Formally, "Not relevant."
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Updated on 10/05/2010 and displayed until 13/09/2011
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 04-May-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sertion 6.5 now reads:
Pressurised aerosol. Pack sizes 50 ml, 250 ml, 75 ml, 150 ml, 200 ml, 300 ml, 400 ml, and 500 ml.
Not all pack sizes may be marketed.
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Updated on 30/06/2009 and displayed until 10/05/2010
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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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| Date of revision of text on the SPC: 23-Jun-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - The folowing text is now included
Patients being dispensed or treated with large quantities (> 100g) of any paraffin based product should be advised to regularly change clothing or bedding impregnated with the product and keep away from naked flames as there is a fire hazard.
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Updated on 07/12/2006 and displayed until 30/06/2009
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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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