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Medical devices: how to stay included (TGA - Therapeutic Goods Administration)

Edit Public Technologies 19 May 2016
TGA - Therapeutic Goods Administration) ... A post-market regulatory affairs representative from your organisation is invited to attend a medical device post-market workshop hosted by the TGA ... A TGA workshop about your post-market responsibilities' ... If you are interested in attending one of these workshops, please email iris@tga.gov.au(link sends e-mail) with the following information....

Children's Panadol 5-12 years suspension 200 mL bottle (TGA - Therapeutic Goods Administration)

Edit Public Technologies 19 May 2016
TGA - Therapeutic Goods Administration). Consumers and health professionals are advised that GlaxoSmithKline Consumer Healthcare Australia, in consultation with the TGA, is in the process of recallingthree batches of Children's Panadol 5-12 years suspension, supplied in 200 mL bottles ... Your report will contribute to the TGA's monitoring of these products. The TGA cannot give advice about an individual's medical condition....

Scheduling delegate's final decisions: NCEs, May 2016 (TGA - Therapeutic Goods Administration)

Edit Public Technologies 19 May 2016
TGA - Therapeutic Goods Administration) ... The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of lesinurad, a new chemical entity for a human therapeutic medicine ... Subsection 52E(1) of the Therapeutic Goods Act 1989 The Scheduling Policy Framework scheduling factors The advice of the Advisory Committee on Prescription Medicines The TGA evaluation report The new drug application....

Prescription medicines: registration of new chemical entities in Australia (TGA - Therapeutic Goods Administration)

Edit Public Technologies 19 May 2016
TGA - Therapeutic Goods Administration) ... These are called New Chemical Entities (NCEs) by the TGA ... This decision by the TGA often comes after years of research and development and following a comprehensive review by the TGA scientists and clinicians of the quality, safety and efficacy of the new prescription medicines ... Original documenthttp.//www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia....

Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA - Therapeutic Goods Administration)

Edit Public Technologies 19 May 2016
TGA - Therapeutic Goods Administration) ... The decision to approve an 'extension of indications' or 'new combination' for registered prescription medicines follows a comprehensive review by TGA scientists and clinicians on the safety and efficacy of the proposed use of the product. Throughout the year we will be publishing information relating to new or extended uses of registered prescription medicines on the TGA website....

Updates to the Prescribing Medicines in Pregnancy database (TGA - Therapeutic Goods Administration)

Edit Public Technologies 19 May 2016
(Source. TGA - Therapeutic Goods Administration). The Prescribing Medicines in Pregnancy database has been updated as follows. NCEs. The following recently registered NCEs have been added to the database ... TGA - Therapeutic Goods Administration published this content on 19 May 2016 and is solely responsible for the information contained herein ... Original documenthttp.//www.tga.gov.au/updates-prescribing-medicines-pregnancy-database ... (noodl....

Children's Panadol batches recalled over contamination

Edit Sydney Morning Herald 19 May 2016
The particles may not be visible, and would be low in number, it said. The TGA warned customers not to use Children's Panadol they had bought if their bottle was from one of the affected batches, which were numbered 136418, 136444 and 136443 ... ....

OTC Codeine real-time monitoring system can succeed (ASMI - Australian Self-medication Industry Inc)

Edit Public Technologies 18 May 2016
(Source. ASMI - Australian Self-medication Industry Inc). 17 May 2016. Return to Media Release Index. OTC Codeine real-time monitoring system can succeed ... This was in response to a report published inAddictiontitled 'Codeine Misuse in Australia' ... The TGA is expected to make a final decision on the possible rescheduling to prescription-only of codeine-containing medicines after June. -ENDS-. [1] Dobbin M ... (noodl. 33608641) ....

Updating medicine ingredient names - information for sponsors (TGA - Therapeutic Goods Administration)

Edit Public Technologies 17 May 2016
TGA - Therapeutic Goods Administration) ... Where a change is needed to a label or PI document, sponsors must submit to TGA a copy of the updated label and PI document for approval ... For OTC and Registered complementary medicines, use the change code 'IHN' (category 'Other') in TGA Business Services for the ingredient name changes ... Where a change is needed to a label on a listed medicine, sponsors do not need to provide these to the TGA....

ASMI Response to Four Corners Program (ASMI - Australian Self-medication Industry Inc)

Edit Public Technologies 17 May 2016
In Australia, complementary medicines are regulated by the Therapeutic Goods Administration (TGA). This is considered one of the most rigorous systems for regulating supplements in the world, and companies marketing complementary medicines must comply with a range of TGA requirements ...  The TGA conducts a safety assessment on ingredients in Listed (displaying an AUST L number) complementary medicines....

HeartWare external controller (TGA - Therapeutic Goods Administration)

Edit Public Technologies 17 May 2016
TGA - Therapeutic Goods Administration). Consumers and health professionals are advised that HeartWare, in consultation with the TGA, has issued a hazard alertfor its HeartWare external controller ... Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). The TGA cannot give advice about an individual's medical condition....

Therapeutic goods determinations (TGA - Therapeutic Goods Administration)

Edit Public Technologies 17 May 2016
(Source. TGA - Therapeutic Goods Administration) ... Specified foreign countries under section 19A(3) ... Permissible ingredients ... Manufacturing principles ... Things that are not Biologicals ... TGA - Therapeutic Goods Administration published this content on 17 May 2016 and is solely responsible for the information contained herein ... Original documenthttp.//www.tga.gov.au/therapeutic-goods-determinations....

Bulletin from annual general meeting of SciBase Holding AB (publ) on 16 May 2016 (SciBase Holding AB)

Edit Public Technologies 17 May 2016
(Source. SciBase Holding AB). At the annual general meeting of SciBase Holding AB (publ) on 16 May 2016 in Stockholm the shareholders adopted the below resolutions ... The meeting resolved to adopt the profit and loss account and balance sheet for the group and the Company included in the annual report ... Michael Colérus, CFO ... Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States....
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