When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
update date to: January 2009
Date updated to November 2008
Section 4.1 – format/harmonisation of text
Section 4.2 - – format/harmonisation, change in children age limit
Section 4.3 - – format/harmonisation of text
Section 4.4 – format/harmonisation of text
Section 4.5 – format/harmonisation, INR warning updated, additional information
Section 4.6 – format/harmonisation of text
Section 4.7– format/harmonisation of text
Section 4.8 – format/harmonisation including additions and deletion of adverse reaction details
Section 4.9 – format/harmonisation with addition advice.
Section 5.1 – format/harmonisation of text
Section 5.3 – format/harmonisation of text
Section 6.6 – format/harmonisation
Section 10 – updated date of SPC
section 4.1 - indication change to state' Management of moderate to severe pain.'
section 10 - date of revision