Summary of Product Characteristics
last updated on the eMC:
09/05/2012
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 09/05/2012 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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-May-2012 |
| 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, 4.3, 4.4, 4.6, 4.7, 4.8, 4.9 and 5.1 of the SPC, to bring it in line with the reference product: Solian.
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Updated on 10/11/2011 and displayed until 09/05/2012
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 01-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC sections 4.6 and 4.8 have been updated.
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Updated on 04/03/2011 and displayed until 10/11/2011
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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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