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‘‘ What ADRAC can do af­ter re­ceiv­ing re­ports of ad­verse re­ac­tions

Take no ac­tion if it is a well-known, non­se­ri­ous re­ac­tion

Take no ac­tion un­less or un­til ad­di­tional sim­i­lar re­ports are re­ceived

Re­quest ad­di­tional in­for­ma­tion from the re­porter

An­a­lyse Aus­tralian Ad­verse Drug Re­ac­tions Sys­tem data­base re­ports to in­ves­ti­gate po­ten­tial safety sig­nals

Re­quest fur­ther in­for­ma­tion from the drug spon­sor or man­u­fac­turer

Pub­lish data in the Aus­tralian Ad­verse Drug Re­ac­tions Bul­letin or med­i­cal jour­nals to raise aware­ness of the re­ac­tion

Re­fer to other ar­eas of the TGA for fur­ther in­ves­ti­ga­tion, dis­cus­sion of the re­ac­tion with in­ter­na­tional medicines reg­u­la­tory agen­cies

Rec­om­mend to amend the medicine’s prod­uct in­for­ma­tion

Rec­om­mend to re­strict the avail­abil­ity of the medicine

Rec­om­mend to re­move the medicine from the mar­ket

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