| Items | Drug Registration information |
|---|---|
| ID | 2805 |
| No | 2805 |
| Brand Name | ZOLEDRO-DENK 4 MG/5 ML |
| Ingredients | ZOLEDRONIC ACID MONOHYDRATE 0.8528 MG EQ.TO ZOLEDRONIC ACID 0.8 MG |
| Dosage Form | SOLUTION FOR INFUSION |
| Primary Packaging | VIAL |
| Storage | |
| Shelf Life | 3 YEARS |
| Pack Size | BOX OF 1 VIAL X 5 ML |
| Dispensing Category | |
| ATC Classification | |
| Pharmaceutical Class | |
| Indications | PREVENTION OF SKELETAL RELATED EVENTS IN ADULT PATIENTS WITH ADVANCED MALIGNANCIES INVOLVING BONE, TREATMENT OF ADULT PATIENT WITH TUMOUR-INDUCED HYPERCALCAEMIA, TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND IN MEN AT INCREASED RISK OF FRACTURE, INCLUDING THOSE WITH A RECENT LOW TRAUMA HIP FRACTURE, TREATMENT OF OSTEOPOROSIS ASSOCIATED WITH LONG-TERM SYSTEMIC GLUCOCORTICOID THERAPY IN POST-MENOPAUSAL WOMEN AND IN MEN AT INCREASED RISK OF FRACTURE, TREATMENT OF PAGET'S DISEASE OF THE BONE IN ADULTS. |
| Contraindications | |
| Side Effects | |
| Unit Price | |
| EDL | NULL |
| Description | CLEAR, COLORLESS SOLUTION |
| Note | |
| License Owner | VIENGTHONG PHARMA IMPORT-EXPORT SOLE CO.,LTD |
| Manufacturer | SIEGFRIED HAMELN GMBH |
| Country | GERMANY |
| Import Registration No | |
| Import Registration Date | |
| Activity | CERTIFICATE RELEASED |
| Applied Date | |
| FDD Registration No | 06 I 5225/22 |
| FDD Registration Date | 28/03/2025 |
| Expiry Date | 27/03/2030 |