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CMEC Meeting 66, 18 April 2008

Complementary Medicines Evaluation Committee

18 April 2008

Extracted ratified minutes

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CMEC Meeting 66 extracted ratified minutes (pdf,111kb)

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.

Item 2 Confirmation of Draft Minutes of CMEC 65 (22 February 2008)

Recommendation 66.1

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.

Item 4.2 Review of Ligusticum lucidum

Recommendation 66.2

CMEC recommends to the TGA that Ligusticum lucidum is not suitable for use as an ingredient in Listed medicines.

Item 4.3 Vitamin B6 safety - label warning statement

Recommendation 66.3

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."

Item 7.1 Review of Caesalpinia sappan

Recommendation 66.4

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.

Item 7.2 Review of Cedrus atlantica

Recommendation 66.5

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.

Item 7.3 Review of Selaginella tamariscina

Recommendation 66.6

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.

Item 7.4 Review of Psoralea corylifolia

CMEC recommends to the TGA:

Recommendation 66.7.1

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.

Recommendation 66.7.2

That an advisory statement, informing consumers of the photosensitizing potential of psoralen, be included on any product containing preparations of Psoralea corylifolia.

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