Product Dossier
KNT-AMLODIPINE
Product Dossier for KNT-AMLODIPINE (amlodipine, Ipca Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Ipca Pharma
- Active ingredient: amlodipine
- Therapeutic area: Cardiology
- Related brand: NORVASC
- Related brand: CADIVAST
- Related brand: TWYNSTA
- Same area: ATOZET
- Same area: OPSUMIT
I cannot provide a
Brand Dossier for KNT-AMLODIPINE based on the documents supplied.
The first document contains detailed product information for a triple-combination medicine (amlodipine/valsartan/hydrochlorothiazide) marketed under the brand name AMLODIPINE/VALSARTAN/HCT NOVARTIS, which is a different product from KNT-AMLODIPINE.
The second document shows that KNT-AMLODIPINE is a monotherapy formulation containing only amlodipine besylate (5 mg and 10 mg tablets), sponsored by Ipca Pharma, first registered with the ARTG in April 2017.
The documents do not contain sufficient information to complete a Brand Dossier for KNT-AMLODIPINE. To produce an accurate dossier, I would require: — Product information specific to the KNT-AMLODIPINE monotherapy formulation — Approved indications for amlodipine monotherapy in Australia — Dosing guidance for the 5 mg and 10 mg strengths — Safety warnings and contraindications relevant to amlodipine — PBS listing details (if applicable) — Complete regulatory history including any PBAC decisions or AusPAR documentation
I recommend providing the current Australian product information for KNT-AMLODIPINE and any relevant regulatory documentation from the TGA or PBS.