Summary of Product Characteristics
last updated on the eMC:
17/02/2011
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 17/02/2011 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 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6.2 - Incompatibilities
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Change to section 6. 5 - Nature and Contents of Container
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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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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 24-Jan-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - Qualitative and Quantitative Composition
Was: Coal Tar Solution 5% v/w
For a full list of excipients, see 6.1.
Now: The active ingredient is coal tar solution 5% v/w
Excipients: Methyl hydroxybenzoate (E218) 0.10% w/w
Propyl hydroxybenzoate (E216) 0.05% w/w
Hydrogenated polyoxyl castor oil 0.45% w/w
For a full list of excipients, see section 6.1.
Section 4.4 - Special Warnings and Precautions for Use
Added: Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic
reactions that might be delayed.
Section 4.8 - Undesirable Effects
Added: Skin and subcutaneous tissue disorders: (as subheading)
Section 6.1 - List of Excipients
Removed: Polysorbate 80
Ethanol
Changed: 'Complex of esterified essential fatty acids' now called 'vitamin F ethyl ester'
'Water' now 'Purified water'
Section 6.2 - Incompatibilities
Was: None known
Now: Not applicable
Section 6.5 - Nature and Contents of Container
Added: Not all pack sizes may be marketed.
Section 6.6 - Instruction for Use/Handling
Was: No special requirements.
Now: Shake the bottle before use.
Section 9 - Date of First Authorisation/Renewal of Authorisation
Was : 3 November 1999 / 16 October 2003
Now: 3 November 1999 / 23 May 2007
Section 10 - Date of (Partial) Revision of the Text
Was: August 2009
Now: January 2011
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Updated on 26/08/2009 and displayed until 17/02/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 6.1 - List of Excipients
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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: 01-Aug-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 1, the trade name has been changed from "Exorex Lotion 1% w/w cutaneous emulsion" to the following;
1. Trade Name of the Medicinal product
Exorex Lotion 5% v/w Cutaneous Emulsion.
In section 2, the composition has changed from "The active ingredient is an alcoholic extract of prepared coal tar 1% w/w (10mg/g) to the following;
2. Qualitative and Quantitative Composition
Coal Tar Solution 5% v/w.
In section 6.1, one of the excipients has changed i.e. Industrial methylated spirits has been replaced with Ethanol.
and in section 10 the revision of the text has changed from March 2006 to August 2009.
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Updated on 18/07/2006 and displayed until 26/08/2009
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 10/2003 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1
The name has been changed from 'Exorex Lotion' to 'Exorex Lotion 1% w/w Cutaneous Emulsion'.
Section 2
The wording 'For excipients, see 6.1' has been added.
Section 3
The description 'A smooth mustard coloured emulsion' has been added.
Section 6.1
The names of the excipients 'sodium propyl paraben' and 'methyl paraben' have been changed to 'sodium propyl hydroxybenzoate (E217)' and 'methyl hydroxybenzoate (E218)'.
Section 6.4
The wording has been amended from 'Store at room temperature below 25°C' to 'Do not store above 25°C'.
Section 6.6
The wording has been amended from 'None' to 'No special requirements'.
Section 9
The date of renewal has been added '16/10/2003'
Section 10
The date of revision of the text has been updated to 16/10/2003
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Updated on 20/01/2003 and displayed until 18/07/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 14/09/2001 and displayed until 20/01/2003
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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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