Summary of Product Characteristics
last updated on the eMC:
23/01/2012
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 23/01/2012 and displayed until Current
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Reasons for adding or updating:
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Addition of Legal Category
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| Date of revision of text on the SPC: 13-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Legal Catagory:
POM added
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Updated on 01/08/2008 and displayed until 23/01/2012
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 13-Mar-2008 |
| 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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Updated on 14/05/2008 and displayed until 01/08/2008
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Product name to include 'soft'
Section 2: Quantitative information about the excipient 'parahydroxybenzoate'
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Updated on 08/08/2005 and displayed until 14/05/2008
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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 29/04/2005 and displayed until 08/08/2005
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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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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Updated on 22/08/2001 and displayed until 29/04/2005
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Reasons for adding or updating:
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Transferred from eMC version 1
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Addition of joint SPC covering all presentations
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