OZIDAL risperidone 2mg tablet blister pack, Sun Pharma ANZ Pty Ltd, CON-576
Product name
OZIDAL risperidone 2mg tablet blister pack
Sponsor name
Sun Pharma ANZ Pty Ltd
Consent start
Consent no.
CON-576
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
Subparagraph 8(1)(j)(iv) - declaration of substance on medicine label is missing
Paragraph 8(1)(O) - does not have the name of the medicine on at least three
non-opposing sides of the carton. Paragraph 9(3)(a) - the name of the medicine
and the name of the active ingredient on the main label does not appear
cohesive. Subsection 9(5) - the name of the active ingredient on the main label
has a text height of less than 3.0 millimetres.
Therapeutic product type
Prescription medicines