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CMEC Meeting 40, 30 May 2003
Complementary Medicines Evaluation Committee
Extracted ratified minutes
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.
CMEC confirms that the draft Minutes of its previous meeting (CMEC 39, 11 April 2003), as amended, are a true and accurate record of that previous meeting.
CMEC recommends to the TGA that all medicines containing 30 mg or more of nicotinic acid per dosage unit carry the label warning statement "Nicotinic acid may cause a temporary flushing reaction" (or words to that effect).
CMEC recommends to the TGA that isobutylene-isoprene copolymer (butyl rubber) is not suitable for use as an excipient in listed medicines.
CMEC recommends to the TGA that the following two coded indications (from the Electronic Lodgement Facility code tables) are not suitable for use on iron-containing listed medicines:
|IRON 3||Source of iron. For iron deficiency.|
|IRON 4||Source of iron. To compensate for loss of iron from bleeding eg. menstrual bleeding.|
CMEC recommends to the TGA that iron-containing listed medicines should include a label warning statement "Not for the treatment of iron deficiency conditions" (or words to that effect).
|Complementary Medicines Evaluation Committee meeting 40 (pdf)||74KB|