Zoledronic acid PH&T is the generic of ZOMETA (Novartis).

A third-generation bisphosphonate, zoledronic acid binds to hydroxyapatite crystals in the bone matrix, slowing their dissolution and inhibiting the formation and aggregation of these crystals.

THERAPEUTIC AREA
Oncology

PRESENTATION
4 mg/5 ml concentrate for solution for infusion

INDICATION
• Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone.
• Treatment of tumour-induced hypercalcaemia .

DOCUMENTATION
eCTD dossier – Slot 2Q 2011