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Australian Register of Therapeutic Goods (ARTG) results
The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia. More...
- ARTG summary
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Product Information:
1. PI for ARTG ID 53377 (pdf) -
Consumer Medicines Information:
1. CMI for ARTG ID 53377 (pdf)
More results from the ARTG ▸
Website results
These results do not include items from TGA's databases, such as the Database of Adverse Event Notifications, the System for Australian Recall Actions and Medicines Shortages Information.
Fully-matching results
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Australian Adverse Drug Reactions Bulletin article index
https://www.tga.gov.au/australian-adverse-drug-reactions-bulletin-article-index1 Feb 2010: Antihistamines and cardiac arrhythmias (astemizole, terfenadine) 12(3) Aug 93. Augmentin jaundice Nov 90. ... Ketoconazole and the liver Nov 82. Ketoconazole and the liver - a reminder Feb 87.
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Guidance 5: Pre-submission meetings with the TGA
https://www.tga.gov.au/sites/default/files/pm-argpm-guidance-5-140519-01.pdf23 Apr 2015: Organising the meeting dossier ------------------------------------------------------------6 The content of a meeting dossier for pre-submission meetings -----------------6. ... Organising the meeting dossier. The content of a meeting dossier for
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TGA advisory committee guidelines: Declarations of interests,…
https://www.tga.gov.au/sites/default/files/tga-advisory-committee-guidelines-160907.pdf7 Sep 2016: Subregulation 42(4) to (7) requirements in relation to a committee meeting __________________________________________________________________________ 11. ... 3. Meeting procedures Each committee meeting will have a standing item on its agenda to consider
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TGA advisory committee guidelines - Declarations of interests,…
https://www.tga.gov.au/sites/default/files/tga-advisory-committee-guidelines-1503.pdf24 Mar 2015: H. Other matters _________________________________________ 15 Freedom of Information (FOI) _____________________________________________________ 15 Working documents ________________________________________________________________ 16 Comcover
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FOI 014-1415 document 21
https://www.tga.gov.au/sites/default/files/foi-014-1415-21.pdf16 Feb 2015: COMMITTEE-IN-CONFIDENCE. Advisory Committee on the Safety of Medicines- 13th Meeting Ratified Minutes with COl declarations removed. ... Advisory Committee on the Safety of Medicines- 13th Meeting Ratified Minutes with COl declarations removed.
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FOI 014-1415 document 24
https://www.tga.gov.au/sites/default/files/foi-014-1415-24.pdf16 Feb 2015: Advisory Committee on the Safety of Medic ines-16th Meeting Ratified Minutes with COl dec larations removed. ... Advisory Committee on the Safety of Medic ines- 16th Meeting Ratified Minutes with COl declarations removed.
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ACSOM meeting statements
https://www.tga.gov.au/acsom-meeting-statementsAdvisory Committee on the Safety of Medicines. 2016. ... Category:. Advisory bodies/Committees. Tags:. ACSOM, committee statements. URL:.
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ACPM meeting statements
https://www.tga.gov.au/acpm-meeting-statements12 Apr 2016: ACPM meeting statements. Advisory Committee on Prescription Medicines. 12 April 2016. ... Category:. Advisory bodies/Committees. Tags:. ACPM, committee statements. URL:.
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Guidance 5: Pre-submission meetings with TGA
https://www.tga.gov.au/guidance-5-pre-submission-meetings-tga12 Jul 2013: The content of a meeting dossier for pre-submission meetings. Include, for the meeting agenda:. ... 5.3 How pre-submission meetings are conducted. A TGA officer facilitates the meeting and will usually begin with:.
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ACMD meeting statements
https://www.tga.gov.au/acmd-meeting-statementsACMD meeting statements. Advisory Committee on Medical Devices. 2016. ... Category:. Advisory bodies/Committees, Medical devices/IVDs. Tags:. ACMD, committee statements. URL:.
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FOI 014-1415 document 22
https://www.tga.gov.au/sites/default/files/foi-014-1415-22.pdf16 Feb 2015: Advisory Committee on the Safety of Medicines - 14th Meeting Ratified Minutes with COl declarations removed. ... Advisory Committee on the Safety of Medicines -14th Meeting Ratified Minutes with COl declarations removed.
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Reasons for scheduling delegate's interim decision and invitation for …
https://www.tga.gov.au/sites/default/files/reasons-scheduling-delegates-interim-decision-and-invitation-further-comment-acms-june-2015.pdf5 Jun 2015: This document was to be provided to members for information. National Drugs and Poisons Schedule Committee – October 2003 The Committee considered post-meeting submissions in relation to the June 2003 initial ... The Committee confirmed the view taken
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Scheduling delegate's interim decisions and invitation for further…
https://www.tga.gov.au/book/part-interim-decisions-matters-referred-expert-advisory-committee-acms14-11-133 Jun 2015: The Committee considered post-meeting submissions in relation to the June 2003 initial decision to reschedule levonorgestrel in a two-tablet pack, of 0.75 mg per tablet, for emergency ... The Committee confirmed the view taken at the June 2003 Meeting
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Scheduling delegate's final decisions: ACMS and NCEs, July 2015: Part …
https://www.tga.gov.au/book/part-final-decisions-matters-referred-expert-advisory-committee-322 Jul 2015: The Committee considered post-meeting submissions in relation to the June 2003 initial decision to reschedule levonorgestrel in a two-tablet pack, of 0.75 mg per tablet, for emergency ... The Committee confirmed the view taken at the June 2003 Meeting
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FOI 014-1415 document 20
https://www.tga.gov.au/sites/default/files/foi-014-1415-20.pdf16 Feb 2015: Advisory Committee on the Safety of Medicines 11th Meeting Ratified Minutes with COls removed. ... Page 4of26. Advisory Committee on the Safety of Medicines 11th Meeting Ratified Minutes with COls removed.
