CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle, Mylan Health Pty Ltd, CON-233
Product name
CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle
Sponsor name
Mylan Health Pty Ltd
Consent start
Consent no.
CON-233
Standard
Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.
Non-compliance with standard
- The main label does not specify the quantity of the active ingredient in mg
(as listed on the ARTG), although the quantity is clearly specified in Ph.
Eur.units. - The name of the medicine and the active ingredient and quantity are
not expressed as a cohesive unit on separate lines of text. - The active
ingredient and quantity of the active ingredient is not displayed in a text
height of not less than 3mm in height.
Conditions imposed
Labels to which this consent applies are those specified in the request
submitted.
Therapeutic product type
Prescription medicines