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CMEC Meeting 70, 5 December 2008
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
This summary is posted shortly after the CMEC meeting to give quick notification of certain recommendations made by CMEC to the TGA. The TGA is yet to consider these recommendations and so this summary does not represent final decisions of TGA and should not be taken as such.
Reasons underlying these recommendations will be available after ratification of the Minutes at the next CMEC meeting. Other recommendations may be made at CMEC meetings but, because they concern confidential matters, or matters requiring further consideration by the TGA, they are not available for public disclosure.
CMEC confirms that the draft Minutes of its previous meeting (CMEC 69, 10 October 2008), as amended, are a true and accurate record of that meeting.
CMEC recommends to the TGA that unprocessed preparations of the fruit or seed, and processed preparations of the seed (as described in the current edition of the Pharmacopoeia of the People's Republic of China) of Quisqualis indica, remain suitable as ingredients in Listed medicines, subject to a maximum recommended daily dose equivalent to 12g of the dried fruit, and 9g of the dried seed.
CMEC recommends to the TGA that Bovine Whey Immunoglobulin (BWI) is suitable for use as an active ingredient in Listed therapeutic medicines, where supported by appropriate evidence for any indications and claims made for the product.
CMEC recommends to the TGA that the use of magnesium sulfate in medicines be referred to the National Drugs and poisons Schedule Committee (NDPSC) to consider if there should be restrictions on access to certain doses of magnesium sulfate when used for human therapeutic purposes, with particular emphasis on appropriate warnings, dosage form, and the amount of the ingredient appropriate for use as a single bolus dose.
|CMEC 70 Extracted Ratified Minutes (pdf)||129KB|