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.
Change to section 4.4 (patient selection) - Special warnings and precautions for Use
Type II variation (EMEA/H/C/833/II/03) - Update to several sections of the SmPC for alignment with the CCDS and Package Leaflet. The phone numbers in the list of local representatives in the Package Leaflet have been updated. Addition of key elements for Patients and Health Care Professionals Educational Materials in Annexes IIb/IV.
Type II variation (EMEA/H/C/833/II/04) - Update to sections 4.2 and 5.1 of the SmPC following a new bioequivalence study comparing the placement of the tablet between the cheek and the gum or sublingually. The Package Leaflet is updated accordingly.
Type II variation (EMEA/H/C/833/II/05) - Update to section 5.3 of the SmPC to reflect results of newly completed carcinogenicity and developmental/reproductive studies.