ALUSTAL OLIVE TREE EXTRACT olea europaea injection suspension vial composite pack, Stallergenes Greer Australia, CON-722
Product name
ALUSTAL OLIVE TREE EXTRACT olea europaea injection suspension vial composite pack
Sponsor name
Stallergenes Greer Australia
Consent start
Consent no.
CON-722
Standard
Section 6, paragraphs 8(1)(n) and 8(1)(o), subsection 9(5), paragraphs 10(4)(c), 10(4)(d), 10(4)(j) and 11(1)(a) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
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;.
Therapeutic product type
Prescription medicines