Product Dossier
AMCAL
Product Dossier for AMCAL (codeine phosphate hemihydrate, ibuprofen, Noumed Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by…
- Sponsor: Noumed Pharmaceuticals
- Active ingredient: codeine phosphate hemihydrate, ibuprofen
- Therapeutic area: Pain Management
- Related brand: PANAMAX
- Related brand: PANADEINE
- Related brand: PEDEA
- Same area: PALEXIA
- Same area: OXYCONTIN
I cannot write a
Brand Dossier for AMCAL Ibuprofen Plus Codeine based on the provided documents.
While the ARTG records confirm that AMCAL IBUPROFEN PLUS CODEINE is a film-coated tablet registered as ARTG 227475 and was first listed 2014-09-01 , the source documents do not contain the product information necessary to complete the dossier sections you have requested.
The first document provides detailed product information only for Aspen Codeine (codeine phosphate hemihydrate alone), not for the combination product AMCAL Ibuprofen Plus Codeine. The second document contains only ARTG registration dates and does not include approved indications, dosing, safety warnings, contraindications, PBS listing details, or regulatory history specific to this combination medicine.
To prepare an accurate Brand Dossier for AMCAL Ibuprofen Plus Codeine, I would require: — Product Information document for the AMCAL brand combination product — PBS listing details (if applicable) — Regulatory history and PBAC outcomes specific to this formulation — Safety and dosing information for the ibuprofen–codeine combination