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334 result(s) found, displaying 201 to 225
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Regulatory decision noticesThe Minamata Convention facilitates a global approach to address concerns relating to mercury, which is persistent, toxic and highly mobile in the environment once released, and recognised as a substance producing significant neurological and other effects in humans.
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Safety updatesProduct Information documents for parenteral iron products are currently being updated to include information about fetal bradycardia and Kounis syndrome.
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Safety updatesThe Product Information for nifedipine has been updated to provide new information about the risk of acute pulmonary oedema when used as a tocolytic agent (inhibiting myometrial smooth muscle contractions) for the treatment of preterm labor in pregnancy.
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Safety updatesThe Product Information for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.
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Safety updatesHealth professionals are advised that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy.
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Regulatory decision noticesThis instrument is made under subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.
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Safety updatesHealth professionals are advised that the Product Information (PI) documents for combined oral contraceptives containing dienogest have been updated to include more detailed information on the risk of venous thromboembolism.
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Safety updatesHealth professionals are advised that the Product Information (PI) documents for sertraline have been updated to include microscopic colitis as a potential adverse effect of unknown frequency based on post-marketing experience.
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Safety updatesThe recommended duration of contraception after finishing tamoxifen treatment has been extended from two months to nine months.
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Safety updatesConsumer goods with button batteries
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Regulatory decision noticesDirection Notice issued to cease advertising of therapeutic goods not entered in the ARTG
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Safety updatesMedicines Safety Update article
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Regulatory decision noticesNew legislative instrument
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesMr Leyonhjelm was directed to cease advertising a prescription medicine for the treatment of Covid-19.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Indications) Determination has been updated
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Regulatory decision noticesAn independent review of the impact of the reforms to the therapeutic goods advertising framework has commenced.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 41FDB, 41FF and 41FH of the Act