Summary of Product Characteristics
last updated on the eMC:
03/01/2012
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 03/01/2012 and displayed until Current
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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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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 20-Dec-2011 |
| 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 of the SPC by including dosing charts. To also amend sections 2, 3, and 9 of the SPC and consequently the leaflet in order to bring them in line with PL 04425/0185 and PL 04425/0187.
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Updated on 01/12/2011 and displayed until 03/01/2012
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 - correction of date of revision
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Updated on 26/07/2011 and displayed until 01/12/2011
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 13-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 text added:
Enoxaparin binds to anti-thrombin III leading to inhibition of coagulation factors IIa and Xa.
Enoxaparin has been shown to increase the blood concentration of Tissue Factor Pathway Inhibitor in healthy volunteers.
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Updated on 11/03/2011 and displayed until 26/07/2011
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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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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