Summary of Product Characteristics
last updated on the eMC:
30/07/2008
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 30/07/2008 and displayed until Current
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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 10 date of revision of the text
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 01-Nov-2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 4.2, 4.3, 4.4 : change in order to be in line with SmPC of Phenylephrine 2.5%
Section 10: update of revision date: 11/2006
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Updated on 18/09/2007 and displayed until 30/07/2008
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 2: BP replaced by PhEur
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Updated on 24/04/2006 and displayed until 18/09/2007
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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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