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What's new
122 result(s) found, displaying 1 to 25
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PageKey information about the shortage for patients, carers and health care professionals
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Meeting statementsOverview of the meeting to discuss proposed changes to the Authorised Prescriber application process
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News articlesWe have updated the rules for lawfully handling vaping products in Australia. These changes make it clearer for businesses that need to lawfully possess and supply vaping goods as part of their operations.
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PageSearch the prescribing medicines in pregnancy database.
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DatasetSearch approvals to import and supply medicines not in the ARTG to address medicine shortages.
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News articlesThe Prescription Medicines in Pregnancy database has been updated to include new entries.
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ServiceAs a medical practitioner, you can apply to access an unapproved therapeutic good for a class of patients with the same condition.
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Prescription medicine decision summaryAlyftrek (vanzacaftor, tezacaftor, deutivacaftor) has been approved to treat people with cystic fibrosis who are 6 years and older. It has 3 active ingredients that target the genetic cause of cystic fibrosis.
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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DatasetSearch our database of sponsor-requested cancellations from the Australian Register of Therapeutic Goods (ARTG).
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Prescription medicine decision summaryEkterly (sebetralstat) has been approved for hereditary angioedema (HAE) attacks caused by C1 inhibitor deficiency or dysfunction, in patients aged 12 years and older.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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Australian public assessment report (AusPar)Opuviz, a bioisimilar to Eylea, has been approved for multiple eye-related conditions.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Media releasesWe have received an internationally recognised designation from the World Health Organization (WHO), reaffirming our role as a trusted global medicines regulator ensuring medicines and vaccines meet the highest international standards for quality, safety and efficacy.
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Media releasesOn Thursday 18 December, following an investigation into the suspected illegal supply and manufacture of vaping substances, the TGA led a major operation targeting illicit vaping products at 2 locations in Bendigo.
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CommitteeInformation on the role and membership of ACB and proposed meeting dates.
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CommitteeInformation on the role and membership of ACCS and proposed meeting dates and decision timeframes.