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CMEC Meeting 66, 18 April 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 65, 22 February 2008), as amended, are a true and accurate record of that meeting.
CMEC recommends to the TGA that Ligusticum lucidum is not suitable for use as an ingredient in Listed medicines.
CMEC recommends to the TGA that the current label warning statement for products containing from 50 to 200 mg vitamin B6 (pyridoxine, pyridoxal, pyridoxamine) per recommended daily dose be amended as follows:
for single ingredient products:
"WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible."
for multi-ingredient products:
"WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6."
CMEC recommends to the TGA that the use of Caesalpinia sappan as an ingredient in Listed medicines should be limited to traditional preparations of the heartwood.
CMEC recommends to the TGA that only an essential oil preparation of the wood of Cedrus atlantica, when administered topically or via inhalation, is suitable for use in Listed medicines.
CMEC recommends to the TGA that the use of Selaginella tamariscina as an ingredient in Listed medicines should be limited to traditional preparations of the herb.
CMEC recommends to the TGA:
That the use of Psoralea corylifolia as an ingredient in Listed medicines should be limited to preparations of the fruit/seed containing less than 1.1 per cent psoralen per recommended daily dose.
That an advisory statement, informing consumers of the photosensitizing potential of psoralen, be included on any product containing preparations of Psoralea corylifolia.
|Complementary Medicines Evaluation Committee meeting 66 (pdf)||111KB|