Summary of Product Characteristics
last updated on the eMC:
19/12/2011
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 19/12/2011 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 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 30-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update section 4.2 (posology and method of administration) of the SPC to bring it in line with the agreed CSP following the completion of a PSUR work sharing procedure and to make a minor amendment to section 6.6 in line with QRD.
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Updated on 17/10/2011 and displayed until 19/12/2011
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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: 21-Apr-2011 |
| 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 23/06/2011 and displayed until 17/10/2011
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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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: 21-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the SPC sections 4.5, 4.6, 4.8 & 10 in line with the agreed Core Safety Profile following PSUR worksharing procedure.
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Updated on 01/04/2011 and displayed until 23/06/2011
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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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