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.
Section 4.8 - Addition of Stevens-Johnson syndrome, toxic epidermal necrolysis as very rare side effects. Addition of Extravasation as a rare side effect. Footnote under Table 1 added to state: "As reported in the postmarketing surveillance of Abraxane" section 6.5 - Addition of generic drug name. Section 6.6 - Addition of paragraph regarding extravasation and addition of generic drug name in third paragraph. Section7.0 - Change of address Section 10.0 - update to 07/2011