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Collection content
103 result(s) found, displaying 1 to 10
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Medicine shortage alertsWe have approved overseas-registered substitutes for Pegasys 135 micrograms/0.5 mL and 180 micrograms/0.5 mL pre-filled syringes.
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Medicine shortage alertsA new 3 mL presentation of Ozempic 0.25 mg/0.5 mg pre-filled pen is now available to replace the 1.5 mL presentation, which is being discontinued.
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PageFind out about the shortage of Pegasys (peginterferon alfa-2a) injection.
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PageKey information and updates about the shortage of metformin immediate-release tablets.
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PageInformation for sponsors on demonstrating stability of medicines under Australian conditions.
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PageHow to submit nonclinical studies in Module 4 of the Common Technical Document (CTD).
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PageExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
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PageUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver.
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PageInformation on special considerations required for medicines for use in special populations.
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PageInformation for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.