Changes to mesalazine from 1 October 2019

Page last updated: 4 October 2019

On 1 October 2019, the authority requirement for item 11210B mesalazine 800 mg enteric tablet, 90  (Asacol, EU) has changed from STREAMLINED to Authority Required (Telephone), in advance of this brand of oral mesalazine delisting from the PBS on 1 April 2020.

Also as of 1 October 2019, the clinical criteria on hypersensitivity to sulphonamide or intolerance to sulfasalazine has been removed from all other oral mesalazine brands other than Asacol^® (listed below), in addition to changing them from Authority Required (STREAMLINED) items to Restricted Benefit items:

• item 8599N mesalazine 1 g modified release granules, 100 sachets  (Salofalk, OA)
• item 9206M mesalazine 1.5 g modified release granules, 60 sachets  (Salofalk, OA)
• item 10257W mesalazine 3 g modified release granules, 30 sachets  (Salofalk, OA)
• item 8598M mesalazine 500 mg modified release granules, 100 sachets  (Salofalk, OA)
• item 2234N mesalazine 1 g modified release granules, 120 sachets  (Pentasa, FP)
• item 2287J mesalazine 2 g modified release granules, 60 sachets  (Pentasa, FP)
• item 10254Q mesalazine 4 g modified release granules, 30 sachets  (Pentasa, FP)
• Item 11554D mesalazine 1 g enteric tablet, 60 (Salofalk, OA)
• Item 3413P mesalazine 1 g modified release tablet, 60 (Pentasa, FP)
• Item 9353G mesalazine 1.2 g modified release tablet, 60 (Mezavant, ZI)
• Item 1611T mesalazine 250 mg enteric tablet, 100 (Mesasal, GO)
• Item 8731M mesalazine 500 mg enteric tablet, 100 (Salofalk, OA)
• Item 2214M mesalazine 500 mg modified release tablet, 100 (Pentasa, FP)