ALUSTAL EXTRACT OF FIVE GRASSES 10 IR/mL injection suspension vial, Stallergenes Greer Australia, CON-722

The products do not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that Section 6 - the product's active ingredient names are the abbreviated Latin species names for the various plant or animal sources. These do not match the Australian Approved Names (AAN) that provide the species names in full Paragraph 8(1)(n) - the outer container label does not include a machine readable code. A machine readable code is included on the individual vial labels Paragraph 8(1)(o) - the name of the medicine is not on at least three non-opposing sides of the carton Subsection 9(5) - the name of active ingredient and quantity or proportion is included in a text size of less than 3.0mm, i.e. restricted to a letter height of 1.5mm Paragraphs 10(4)(c) and 10(4)(d) - the name of the medicine and the name of the active ingredients on a container containing 25mL or less is included in a text size of less than 2.0mm, i.e. restricted to a letter height of 1.5mm Paragraph 10(4)(j) - the product vials do not include the Sponsor name or logo Paragraph 11(1)(a) - quantities are not expressed according to appropriate metric units. On the outer label and the container label the unit for millilitre used is quot;ml quot; at various places instead of quot;mL quot;.