View drug registration information details.
| Items | 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 |
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| Primary Packaging | VIAL |
|---|
| Storage | |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 1 VIAL X 5 ML |
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| Dispensing Category | |
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| ATC Classification | |
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| Pharmaceutical Class | |
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| 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. |
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| Contraindications | |
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| Side Effects | |
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| Unit Price | |
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| EDL |
NULL |
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| Description | CLEAR, COLORLESS SOLUTION |
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| Note | |
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| License Owner | VIENGTHONG PHARMA IMPORT-EXPORT SOLE CO.,LTD |
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| Manufacturer | SIEGFRIED HAMELN GMBH |
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| Country | GERMANY |
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| Import Registration No | |
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| Import Registration Date | |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | |
|---|
| FDD Registration No | 06 I 5225/22 |
|---|
| FDD Registration Date | 28-Mar-2025 |
|---|
| Expiry Date | 27-Mar-2030 |
|---|
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