Summary of Product Characteristics
last updated on the eMC:
05/07/2011
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 05/07/2011 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 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 4.5 - 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 4.9 - Overdose
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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: 23-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the relevant SPC sections in line with agreed Core Safety Profile following Periodic Safety Update Report worksharing procedure
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Updated on 03/02/2011 and displayed until 05/07/2011
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Reasons for adding or updating:
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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: 10-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC replaced with the most current version, date of revision changed from Oct 2008 to 10/11/2010.
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Updated on 30/12/2008 and displayed until 03/02/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To register a change in imprints on the finished product, from 'ROCHE' on the cap and body of the capsule to the Actavis logo on the cap and the pharmaceutical strength on the body of the capsule.
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Updated on 24/09/2008 and displayed until 30/12/2008
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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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