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SALOFALK ENEMAS mesalazine 4g/60 mL enema bottle, Dr Falk Pharma Australia Pty Ltd, CON-529
Product name
SALOFALK ENEMAS mesalazine 4g/60 mL enema bottle
Sponsor name
Dr Falk Pharma Australia Pty Ltd
ARTG details
- AUST R 80652
Batches
Batches 190408A, 190409A, 190686A, 190687A, 190854A, 190855A, 200026A, 200027A, 200028A, 200029A, 200030A, 200156A, 200157A, 200158A, 200159A
Consent start
Consent no.
CON-529
Duration
The consent is effective from the 6 August 2020 until 6 August 2022
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].
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines