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CMEC Meeting 50, 11 February 2005

Complementary Medicines Evaluation Committee

11 February 2005

Extracted ratified minutes

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CMEC Meeting 50 extracted ratified minutes (pdf,93kb)

Public recommendation summary

This summary has been posted immediately after the CMEC meeting to give quick advice of the recommendations made by CMEC to the TGA. This summary does not represent the decisions of TGA. Reasons underlying these recommendations will be available after Members ratify the Minutes at the next CMEC meeting.

Item 2 Minutes of CMEC's 49th meeting

Recommendation 50.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 49, 10 December 2004), as amended, are a true and accurate record of that meeting.

Item 5.1 Action arising from previous meetings - Asparagus racemosus

Recommendation 50.2

CMEC recommends to the TGA that Asparagus racemosus dried, peeled root, and water extracts or ethanol and water extracts (containing up to 45% ethanol) of the dried, peeled root, are suitable for use as an ingredient in listed medicines.

Item 10 Matters referred from within TGA

Item 10.2 Matters referred from within TGA - Larrea tridentata (Chaparral) - warning statement

Recommendation 50.6

CMEC recommends to the TGA that the current label warning statement,

"Warning: Chaparral may harm the liver in some people. Use only under the supervision of a healthcare professional"

for listed medicines containing Larrea tridentata (Chaparral) is adequate.

Recommendation 50.7

CMEC recommends to the TGA that homoeopathic preparations that contain Larrea tridentata (Chaparral) in concentrations more dilute than 1000-fold dilution of the mother tincture be exempt from the label warning statement requirement.

Item 10.3 Matters referred from within TGA - Chelidonium majus (Greater celandine) - warning statement

Recommendation 50.8

CMEC recommends to the TGA that the following label statement for listed medicines containing Chelidonium majus (Greater Celandine) be required:

"Warning: Greater Celandine may harm the liver in some people. Use only under the supervision of a healthcare professional".

Recommendation 50.9

CMEC recommends to the TGA that homoeopathic preparations that contain Chelidonium majus (Greater Celandine) in concentrations more dilute than 1000-fold dilution of the mother tincture be exempt from the label warning statement requirement.

Item 10.3 Matters referred from within TGA - Hypericum perforatum (St John's wort) - warning statement

Recommendation 50.10

CMEC recommends to the TGA that the current label statement for products containing Hypericum perforatum (St John's wort) be amended to the following:

"St Johns Wort affects the way many prescription medicines work, including the oral contraceptive pill. Consult your doctor".

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