Summary of Product Characteristics
last updated on the eMC:
07/08/2009
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 07/08/2009 and displayed until Current
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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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| Date of revision of text on the SPC: 24-Apr-2004 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.6 the following statement has been removed
"Use during pregnancy and lactation is not contraindicated. However, as with all medicines during this period, caution should be exercised."
It has been replaced with
"For Eno no clinical data on exposed pregnancies are available.
Animal studies on each of the active ingredients do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when recommending to pregnant women."
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Updated on 18/03/2009 and displayed until 07/08/2009
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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