URSOFALK ursodeoxycholic acid 250 mg capsule blister pack, Dr Falk Pharma Australia Pty Ltd, CON-529
Product name
URSOFALK ursodeoxycholic acid 250 mg capsule blister pack
Sponsor name
Dr Falk Pharma Australia Pty Ltd
Batches
Batches L19118A, L19168A, L20026A, L20092A, L20093A
Consent start
Consent no.
CON-529
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not conform to the requirements of Paragraph 8(1)(i) of
Therapeutic Goods Order No. 91, in that the product labels do not include the
name and address of the current sponsor (Dr Falk Pharma Australia Pty Ltd) and
instead refer to the previous sponsor (Orphan Australia).
Conditions imposed
The labels to which this consent applies are those previously approved for the
former sponsor Orphan Australia and arrangements are in place with the former
sponsor for the prompt referral of any queries or complaints concerning the
products to Dr Falk Pharma Australia Pty Ltd [the current sponsor].
Therapeutic product type
Prescription medicines