MAYNE PHARMA 5FU fluorouracil 5% w/w cream tube, Mayne Pharma International Pty Ltd, CON-1215
Product name
MAYNE PHARMA 5FU fluorouracil 5% w/w cream tube
Sponsor name
Mayne Pharma International Pty Ltd
Consent start
Consent no.
CON-1215
Duration
The consent is effective from 10 January 2024 until 10 January 2026 or until the criteria in BP Appendix XVI C. Efficacy of Antimicrobial Preservation for A. brasiliensis is revised, whichever occurs first.
Standard
Section10 of Therapeutic Goods Order No. 100 - Therapeutic Goods (Microbiological Standards for Medicines) Order 2018
Non-compliance with standard
The product does not comply with the acceptance criteria specified in the
British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for
Aspergillus brasiliensis.
Conditions imposed
1.The product must meet the acceptance criteria for Aspergillus brasiliensis
specified in the USP General Chapter Antimicrobial Effectiveness Testing.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines