Product Dossier
APOC-5FU
Product Dossier for APOC-5FU (fluorouracil 5% w/w, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: fluorouracil 5% w/w
- Therapeutic area: Dermatology
- Same area: DERMATANE
- Same area: NEOTIGASON
What it is
APOC-5FU is a fluorouracil cream formulation containing 5% w/w fluorouracil .
Approved indications
The source documents provided do not contain information about the approved indications for APOC-5FU topical cream. The clinical particulars in the available product information relate to fluorouracil injection, not the cream formulation.
PBS listing
APOC-5FU cream 50 mg per gram (5%) in 20 gram tubes is listed on the PBS with one item, unrestricted access, at an ex-manufacturer price of A$50.40 .
Regulatory history
APOC-5FU fluorouracil 5% w/w cream was first listed on the ARTG on 26 April 2016 under licence category RE .