Summary of Product Characteristics
last updated on the eMC:
04/01/2011
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 04/01/2011 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 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 3 - Shelf Life
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 08-Jan-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 - 'other piperazine derivatives' added to contraindications
Section 4.8 - section reformatted to include new undesirable effects and the incidence
Section 5.3 - reformatted
Section 6.3 - shelf life increased from 2 years to 3 years
Section 7 - MAH changed from APS to TEVA
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Updated on 18/03/2009 and displayed until 04/01/2011
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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