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What's new
191 result(s) found, displaying 126 to 150
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Prescription medicine decision summaryNiktimvo is approved for the treatment of chronic graft-versus host disease (cGVHD). Niktimvo contains the active ingredient axatilimab.
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Prescription medicine decision summaryOrserdu is approved for the treatment of advanced breast cancer in postmenopausal women, and men. Orserdu contains the active ingredient elacestrant.
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PageKey information about the shortage for patients, carers and health care professionals
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PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
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News articlesSponsors and manufacturers intending to export medicines and medical devices to Indonesia should be aware of new and emerging halal certification requirements under Indonesia’s Halal Product Assurance framework.
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FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
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Australian public assessment report (AusPar)Audenz (influenza virus haemagglutinin) is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.
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GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.
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Prescription medicine decision summaryRedemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS).
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BlogDo you know that there are strict rules when it comes to advertising therapeutic goods? If you see an ad that looks like it’s breaking the rules, report it using our online portal.
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PageAdvice on the implications of Brexit for therapeutic goods supply in Australia.
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PageMedical devices priority applicant determination notices and eligibility for priority review pathway.
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PageTGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries.
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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
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Meeting statementsAdvisory Committee on Vaccines meeting statement 56
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PageFind out about our compliance review activities for listed medicines and how to avoid common compliance issues.
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PageThe TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications for exercise performance.
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News articlesThe TGA initiated targeted compliance reviews of select listed medicines containing Magnesium to verify whether sponsors had appropriate evidence to support their medicine’s exercise performance claims.
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Australian public assessment report (AusPar)Ekterly (sebetralstat) has been approved for the treatment of hereditary angioedema attacks caused by C1 inhibitor deficiency or dysfunction in patients aged 12 years and older.
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Safety alertsWe are warning consumers about the risks of importing and using unapproved peptide products that are promoted online.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
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PageExpected new shortage during May 2026 is not occurring.
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Australian public assessment report (AusPar)Calcemic is indicated for active immunisation against the H5 subtype of Influenza A virus in persons from 6 months of age and older. Celldemic should be used in accordance with official recommendations.
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PageApprovals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions.