After thorough evaluation, the Therapeutic Goods Administration (TGA) has reinstated ZANTAC tablets, and they are available to purchase without a prescription in Australia. ZANTAC (ranitidine (as hydrochloride)) tablets help relieve symptoms of heartburn and acid indigestion. They are available across all major Australian pharmacies and supermarkets in two strengths, ranitidine 150mg tablets for 12-hour relief and ranitidine 300mg tablets for 24-hour relief.
Background on reistatement
In September 2019, the TGA removed all medicines containing ranitidine from the Australian market over concerns about the level of nitrosamine impurities in ranitidine products.
Since then, Aspen Pharmacare Australia, the sponsor of ZANTAC tablets, has worked with the TGA to confirm that the level of nitrosamines in ZANTAC tablets remain within internationally accepted limits at the maximum daily dose throughout their shelf life. This has ensured that ZANTAC tablets meet all requirements for registration on the Australian Register of Therapeutic Goods (ARTG).
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