Summary of Product Characteristics
last updated on the eMC:
13/01/2012
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 13/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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 4.8 - Undesirable Effects
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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: 18-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 - Under the title of 'Children' change to 'Paediatric population'
4.3 - Under the title contraindications, 4th paragraph 'nursing mothers' changed to 'breastfeeding'
4.4 - Under the title Psychiatric disorders, add ', including alitretinoin to the end of the first sentence, to read 'suicide attempts and suicide have been reported in patients treated with systemic retinoids, including alitretinoin.'
4.8 - An additional column has been added at the end of the table 'Unknown'
4.8 - An additional row has been added below 'Endocrine Disorders' for 'Physchiatric disorders' with 'Depression, mood changes, suicidal ideation' being added to the Unknown column
6.4 – Under the title Special precautions for storage, temperature conditions removed
10 - Change date from 5 SEPTEMBER 2011 to '18 AUGUST 2011'
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Updated on 19/09/2008 and displayed until 13/01/2012
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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