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Media releases & statements

Contact number for media enquiries: +61 2 6289 7400

2014: Jul Jun May Apr Mar Feb Jan Older

July 2014

Codman Certas Programmable Valves
29 July 2014: Consumers and health professionals are advised that Johnson & Johnson Medical has issued a hazard alert for two Codman Certas Programmable Valve products


Hard Ten Days capsules
18 July 2014: Hard Ten Days capsules pose a serious risk to your health and should not be taken


Zhansheng Weige Chaoyue Xilishi tablets
18 July 2014: Zhansheng Weige Chaoyue Xilishi tablets pose a serious risk to your health and should not be taken


Libigrow capsules
17 July 2014: Libigrow capsules pose a serious risk to your health and should not be taken


Tibet Babao tablets
17 July 2014: Tibet Babao tablets pose a serious risk to your health and should not be taken


Libigrow Xtreme capsules
17 July 2014: Libigrow Xtreme capsules pose a serious risk to your health and should not be taken


Chong Cao Zhag Bian Bao capsules
17 July 2014: Chong Cao Zhag Bian Bao capsules pose a serious risk to your health and should not be taken


Night Man tablets
17 July 2014: Night Man tablets pose a serious risk to your health and should not be taken


HIV self-tests in Australia: Supply restrictions lifted
8 July 2014: The Secretary of the Department of Health has signed the legislative instrument to amend the Therapeutic Goods (Excluded Purposes) Specification 2010 to allow the future supply of HIV self-tests


NexGen Complete Knee Solution MIS stemmed tibial component (various sizes)
9 July 2014: Zimmer has issued a hazard alert regarding its NexGen Complete Knee Solution MIS total knee procedure stemmed tibial component (various sizes)


Update 3: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches
7 July 2014: All sizes and batches of the AFT-distributed Provive and Sandoz Propofol 1% products are no longer under a precautionary supply restriction


Lady-Era tablets
4 July 2014: Lady-Era tablets pose a serious risk to your health and should not be taken


MSA Hip System - femoral hip replacement with modular neck
3 July 2014: Global Orthopaedic Technology is issuing a hazard alert for the MSA Hip System due to it having a higher than expected revision rate


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June 2014

Advisory committees on medicines & chemicals scheduling (ACMS & ACCS)
11 June 2014: Updated ACMS and ACCS meeting dates & decisions timeframes


Seeking TGA statutory advisory committee members
27 June 2014: Expert advisors are being sought from a range of fields


eCTD submission update
24 June 2014: The TGA has been working with stakeholders to prepare for a pilot electronic applications submission programme for registered medicines


Ivabradine (Coralan) and cardiovascular events in patients with angina
23 June 2014: The TGA is reviewing new information regarding ivabradine (Coralan) identified in the preliminary results of a study into the medicine


Required Advisory Statements for Medicine Labels (RASML) and the Labelling Order (TGO 69)
13 June 2014: The newly revised RASML and the amendment to the Labelling Order (Therapeutic Goods Order No. 69D) has commenced on 12 June 2014


BioCSL Fluvax - investigations into the cause of fevers in children under 5 years
12 June 2014: BioCSL has published its research into the cause of fevers in children under 5 years


Accu-Chek Mobile blood glucose meter
6 June 2014: There is a potential for incorrect blood glucose readings as a result of users not following the device instructions


Accu-Chek Spirit Combo insulin pump - serial numbers 10171897 to 10281629
6 June 2014: Users of Accu-Chek Spirit Combo insulin pumps with serial numbers between 10171897 and 10281629 are being notified of a potential fault that may prevent treatment


Pharmacy software vendor links to TGA adverse event reporting web service
4 June 2014: GuildLink is the first company to provide an integrated link to the TGA's new adverse event reporting web service


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May 2014

Cereform breast implants and associated sizers - update
28 May 2014: The TGA has suspended the Cereform silicone gel-filled breast implants and associated sizers from the ARTG


So Hard for Men tablets
26 May 2014: So Hard for Men tablets pose a serious risk to your health and should not be taken


Top Man 3 capsules
26 May 2014: Top Man 3 capsules pose a serious risk to your health and should not be taken


Vigour 800 tablets
26 May 2014: Vigour 800 tablets pose a serious risk to your health and should not be taken


Stree Overlord Strong tablets
26 May 2014: Stree Overlord Strong tablets pose a serious risk to your health and should not be taken


Germany Niubian tablets
26 May 2014: Germany Niubian tablets pose a serious risk to your health and should not be taken


Medicine shortages information now available
26 May 2014: This is provided to assist health professionals and consumers when there is a temporary or permanent disruption (discontinuation) to the supply of a medicine in Australia


The Rock capsules
26 May 2014: The Rock capsules pose a serious risk to your health and should not be taken


My Man His Enhancer 12 Pack tablets
26 May 2014: My Man His Enhancer 12 Pack tablets pose a serious risk to your health and should not be taken


Play Hard for Men capsules
26 May 2014: Play Hard for Men capsules pose a serious risk to your health and should not be taken


Bull's Genital tablets
26 May 2014: Bull's Genital tablets pose a serious risk to your health and should not be taken


REDDES (or REDDIES) capsules
26 May 2014: REDDES capsules pose a serious risk to your health and should not be taken


Black Ant Strong tablets
26 May 2014: Black Ant Strong tablets pose a serious risk to your health and should not be taken


Aquatec Ocean VIP mobile shower and toilet commode
22 May 2014: Invacare Australia is undertaking a recall for product correction of some units of its Aquatec Ocean VIP mobile shower and toilet commode due to an issue with the snap-on connectors that secure the backrest cushion


PIP silicone gel breast implants
19 May 2014: The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks has published the final version of its updated opinion on the safety of PIP silicone gel filled breast implants


MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
15 May 2014: Consumers and health professionals are advised that Baxter Healthcare is undertaking a recall of one lot of its MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp


Zhansheng Weige Cahoyue Xilishi tablets
14 May 2014: Zhansheng Weige Cahoyue Xilishi tablets pose a serious risk to your health and should not be taken


Alere INRatio2 PT/INR heparin-insensitive test strips
8 May 2014: Alere has issued a safety alert for Alere INRatio2 PT/INR heparin-insensitive test strips due to the potential for incorrect INR results


Robust tablets
7 May 2014: Robust tablets pose a serious risk to your health and should not be taken.


Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches
2 May 2014: AFT Pharmaceuticals, in consultation with the TGA, has quarantined two batches of Provive MCT-LCT 1% (propofol 1%) emulsion for injection in 20 ml vials. This action is being taken due to potential contamination with the bacteria Ralstonia pickettii


Maxman II capsules
2 May 2014: Maxman II capsules pose a serious risk to your health and should not be taken


Ying Dao Di capsules
2 May 2014: Ying Dao Di capsules pose a serious risk to your health and should not be taken


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April 2014

Laparoscopic power morcellators
29 April 2014: The US Food and Drug Administration (FDA) has published a safety communication advising against the use of laparoscopic morcellators during certain uterine surgery procedures in patients with fibroids


Craniomaxillofacial Distraction System - BC Distractor Body
29 April 2014: Synthes Australia is issuing a hazard alert for its BC Distractor Body, a component of the Craniomaxillofacial (CMF) Distraction System


Otto Bock A200, Skippi and Skippi Plus power wheelchairs
24 April 2014: Recall for product correction - potential for front wheels to break


Xyntha 500IU dual-chamber syringe - batch number H19478
24 April 2014: Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, is recalling one batch of its Xyntha 500IU dual-chamber syringe


Accu-Chek Mobile glucose tests
22 April 2014: There is a potential for a commonly used antibiotic to interfere with blood glucose test results


MosKa - energy for adults
16 April 2014: MosKa - energy for adults poses a serious risk to your health and should not be taken.


Swanson full spectrum cilantro herbal supplement
16 April 2014: Potential contamination with Salmonella


Medtronic paradigm insulin pump
14 April 2014: A safety advisory to reinforce awareness of the need to confirm insulin dosage when using certain Medtronic Paradigm insulin pumps


Canesten 6 day cream 35 g
14 April 2014: Consumers and health professionals are advised that five batches of the Canesten 6 day cream 35 g are being recalled


Zhen de shou fat loss capsules
11 April 2014: Zhen de shou fat loss capsule pose a serious risk to your health and should not be taken


Consultation on low value turnover exemption (LVT) scheme
10 April 2014: The TGA has commenced a policy and operational review of the low value turnover exemption (LVT) scheme


Upgraded over-the-counter medicines online application system
8 April 2014: The upgraded system will become available on 9 April 2014


EMA and Australian regulatory authority strengthen collaboration in the area of orphan medicines
7 April 2014: The EMA and TGA have agreed to share the full assessment reports related to marketing authorisations of orphan medicines, which are intended to treat rare diseases


Night fat-burning slimming capsules
7 April 2014: Night Fat-burning slimming capsules pose a serious risk to your health and should not be taken


Powerful leg-slimming capsules
7 April 2014: Powerful Leg-slimming capsules pose a serious risk to your health and should not be taken


Pink grain herbal slimming capsules
7 April 2014: Pink Grain Herbal Slimming capsules pose a serious risk to your health and should not be taken


Hydroxyethyl starch (Voluven and Volulyte) and increased risk of mortality
4 April 2014: The TGA has completed its safety review of hydroxyethyl starch


Hydroxyethyl starch (Voluven and Volulyte)
4 April 2014: Consumers and health professionals are advised that a recent safety review of hydroxyethyl starch has found an increased risk of mortality and the need for dialysis when this medicine is used to treat patients with sepsis


Strontium ranelate (Protos) and risk of adverse events
3 April 2014: Consumers and health professionals are advised that Servier Laboratories (Australia) has updated the Product Information (PI) for strontium ranelate (Protos) after the completion of a TGA review


Bexsero meningococcal B vaccine
2 April 2014: Consumers and health professionals are advised that the TGA is undertaking intensive monitoring of the safety and risk profile of Bexsero meningococcal B vaccine following its introduction to the Australian market


Domperidone (Motilium) and effects on the heart
2 April 2014: The TGA is reviewing new information regarding domperidone (Motilium) and its potential effects on the patient's heart, particularly with doses above 30 mg daily


Meizitang Strong Version Botanical Slimming capsules
2 April 2014: Meizitang Strong Version Botanical Slimming soft gel capsules pose a serious risk to your health and should not be taken


Ya Buk capsules
1 April 2014: Ya Buk capsules pose a serious risk to your health and should not be taken


Star Majestic Slimming capsules
1 April 2014: Star Majestic Slimming capsules pose a serious risk to your health and should not be taken


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March 2014

Medtronic SynchroMed II implantable infusion pump
28 March 2014: It has been identified that Medtronic SynchroMed II infusion pumps have the potential for over-infusion


Hospira infusion pumps - Plum family, GemStar and LifeCare models
28 March 2014: New Hospira infusion pumps from the Plum A+ family still cannot be supplied in Australia


VigRX Plus tablets
27 March 2014: VigRX Plus tablets pose a serious risk to your health and should not be taken


VigRX for Men capsules
27 March 2014: VigRX for Men capsules pose a serious risk to your health and should not be taken


Natural-Knee II System metal-backed patella - used in knee replacements
26 March 2014: Zimmer has issued a hazard alert regarding its Natural-Knee II System metal-backed patella


African Superman tablets
25 March 2014: African Superman tablets pose a serious risk to your health and should not be taken


Blue Fantasy capsules
25 March 2014: Blue Fantasy capsules pose a serious risk to your health and should not be taken


Sanovera Starter capsules
25 March 2014: Sanovera Starter capsules pose a serious risk to your health and should not be taken


3X Slimming Power capsule
24 March 2014: 3X Slimming Power capsules pose a serious risk to your health and should not be taken


MME Naturally Maxman capsules
24 March 2014: MME Naturally Maxman capsules pose a serious risk to your health and should not be taken


Tiger King tablets
24 March 2014: Tiger King tablets pose a serious risk to your health and should not be taken


Zi Xiu Tang Beauty Face and Figure capsule
24 March 2014: Zi Xiu Tang Beauty Face and Figure Capsule pose a serious risk to your health and should not be taken


Zi Xiu Tang Pollen capsule
24 March 2014: Zi Xiu Tang Pollen Capsule poses a serious risk to your health and should not be taken


Streamlining and improving therapeutic goods legislation
24 March 2014: Amendments have been made to the Therapeutic Goods Act 1989 (the Act) by the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014


HomeChoice PRO automated peritoneal dialysis system
18 March 2014: Consumers and health professionals are advised that Baxter Healthcare is undertaking a recall for product correction of its HomeChoice Pro automated peritoneal dialysis system


Natalizumab and melanoma
18 March 2014: The TGA is monitoring reports of melanoma in patients being treated with natalizumab


Common list of colouring substances published
17 March 2014: Harmonisation provides manufacturers with expanded range of permitted colours


Medtronic neurostimulation devices used for deep brain, spinal cord and peripheral nerve stimulation therapies - multiple models
17 March 2014: Consumers and health professionals are advised that Medtronic Australasia has issued a hazard alert regarding multiple models of its neurostimulation devices


Review of the colouring substance tartrazine
17 March 2014: Tartrazine now allowed for both oral and topical use


Medtronic spinal cord stimulation devices - multiple models
17 March 2014: Consumers and health professionals are advised that Medtronic Australasia has issued a hazard alert regarding multiple models of its spinal cord stimulation devices


2014 seasonal influenza vaccines
12 March 2014: Influenza vaccines can change from year to year as new strains of influenza virus appear


2014 seasonal influenza vaccines for use in children
12 March 2014: There are four different influenza vaccines registered for use in children from the age of 6 months


Cereform breast implants and associated sizers
11 March 2014: Updated information on the recall of the implants and associated sizers


Upgraded over-the-counter medicines online application system
7 March 2014: From 9 April 2014 over-the-counter medicines applications will be easier to submit and process ...


FreeStyle Papillon Mini blood glucose monitoring system
4 March 2014: FreeStyle Papillon Mini blood glucose monitors can potentially give incorrect blood glucose results ...


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February 2014

Levonorgestrel 1.5 mg and 0.75 mg, oral emergency contraceptive
28 February 2014: The TGA is reviewing recent information that suggests levonorgestrel may not be effective for women who weigh more than 70 kg


Electronic-only (eCTD) submissions milestone reached
26 February 2014: The TGA has signed an agreement for the entry of prescription medicines and other therapeutic products on to the ARTG


Beautiful Slim Body capsules
25 February 2014: Beautiful Slim Body capsules pose a serious risk to your health and should not be taken


Collagen Slim capsules
25 February 2014: Collagen Slim capsules pose a serious risk to your health and should not be taken


Cereform silicone gel-filled breast implants
21 February 2014: The TGA has been advised that non-implanted Cereform silicone gel-filled breast implants have been recalled in France


Medicines with soft gel capsules marketed for children
19 February 2014: Consumers and health professionals are advised that medicines that come in the form of soft gel capsules may pose a choking risk for children, especially those aged under five years


Peristeen anal irrigation system
19 February 2014: Consumers and health professionals are advised that Coloplast has undertaken a recall for product correction for its Peristeen anal irrigation system


Lian Zhan Qi Tian capsules
18 February 2014: Lian Zhan Qi Tian capsules pose a serious risk to your health and should not be taken


Minister lauds 50 years of independent expert advice
13 February 2014: The Australian Government has paid tribute to the work of a committee of eminent health experts


Otto Bock Aerius/Aerial and Aerius/Aerial Active wheelchair cushions
13 February 2014: Routine testing has found that the foam within these cushions becomes more flammable after it has been washed...


First harmonisation activity completed
12 February 2014: New Zealand changes paediatric dosage instructions for paracetamol and ibuprofen to align with Australia


Medtronic SynchroMed II implantable infusion pump system
4 February 2014: Consumers and health professionals are advised that Medtronic Australasia has issued a hazard alert ...


Strontium ranelate (Protos) and risk of adverse events
4 February 2014: The TGA is currently undertaking a review of strontium ranelate (Protos) to assess the risk of adverse events including cardiovascular events


Medtronic deep brain stimulation and spinal cord stimulation devices - multiple models
4 February 2014: Consumers and health professionals are advised that Medtronic Australasia has issued a hazard alert ...


Pilot web service for transmission of adverse event reports from medical software to the Therapeutic Goods Administration
3 February 2014: The TGA invites medical software vendors to participate in a pilot project ...


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January 2014

St Jude Medical Implantable Cardiac Devices when used with Merlin programmer and version 17.2.2 software
28 January 2014: Health professionals are advised that St Jude Medical Australia has issued a hazard alert regarding its Implantable Cardiac Devices


Medtronic Mosaic Porcine Aortic Bioprosthesis
28 January 2014: Medtronic Australasia, in consultation with the TGA, has issued a hazard alert for its Mosaic Porcine Aortic Bioprosthesis Model 305


Liko overhead lifts ceiling-mounted rail systems
21 January 2014: Consumers and health professionals are advised that Hill-Rom is undertaking a recall for product correction regarding ceiling-mounted rail systems


Apple's quick-impact weight loss capsules
17 January 2014: Apple's Quick-Impact Weight Loss capsules pose a serious risk to your health and should not be taken


Super Hard tablets
15 January 2014: Super Hard tablets pose a serious risk to your health and should not be taken


Acai Berry Living-XS Diet capsules
10 January 2014: Acai Berry Living-XS Diet capsules pose a serious risk to your health and should not be taken


Erec-Bull tablets
10 January 2014: Erec-Bull tablets pose a serious risk to your health and should not be taken


Dextropropoxyphene - questions and answers
7 January 2014: Questions and answers on pain-killers containing dextropropoxyphene


Journey Bi-Cruciate Stabilised (BCS) knee replacement system - femoral implant
6 January 2014: Smith & Nephew has issued a hazard alert ...


Grease Discharging Machine Capsules
2 January 2014: Grease Discharging Machine Capsules pose a serious risk to your health and should not be taken


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Historical media releases & statements

Web page last updated: Monday, 19 May 2014

URL: http://www.tga.gov.au/newsroom/media.htm