Summary of Product Characteristics
last updated on the eMC:
27/07/2011
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 27/07/2011 and displayed until Current
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 04-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The mentioned below sections of SPC was amended:
4.8: Undesirable Effects
4.9: Overdose
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Updated on 29/04/2011 and displayed until 27/07/2011
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 14-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Following sections of SPC's have been updated:
4.3: Contra-indications
4.4: Special warnings and precautions for use
4.6: Pregnancy and Lactation
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Updated on 06/08/2009 and displayed until 29/04/2011
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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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