| ID | 523 |
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| No | 523 |
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| Brand Name | HALAVEN SOLUTION FOR INJECTION |
|---|
| Ingredients | EACH VIAL (2 ML) CONTAINS: ERIBULIN MESYLATE 1 MG EQ.TO ERIBULIN 0.88 MG. |
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| Dosage Form | SOLUTION FOR INJECTION |
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| Primary Packaging | VIAL |
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| Storage | STORE BELOW 30'C |
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| Shelf Life | 2 YEARS |
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| Pack Size | BOX OF 1 VIAL X 2ML |
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| Dispensing Category | Prescription only |
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| ATC Classification | L01XX41 |
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| Pharmaceutical Class | ANTINEOPLASTICS |
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| Indications | TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE PROGRESSED AFTER AT LEAST TWO CHEMOTHERAPEUTIC REGIMENS FOR ADVANCED DISEASE. PRIOR THERAPY SHOULD HAVE INCLUDED AN ANTHRACYCLINE AND A TAXANE UNLESS PATIENTS WERE NOT SUITAB |
|---|
| Contraindications | - HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR TO ANY OF THE EXCIPIENTS
- BREAST FEEDING |
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| Side Effects | THE MOST COMMONLY REPORTED ADVERSE REACTIONS TO ERIBULIN ARE SHOWN IN THE TABLE BELOW. |
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| Unit Price | - |
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| EDL |
No |
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| Description | 5 ML CLEAR GLASS VIAL CONTAINING A CLEAR, COLOURLESS SOLUTION ESPECIALLY FREE FROM VISIBLE PARTICLES OF FOREIGN MATTER |
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| Note | |
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| License Owner | DKSH LAOS COMPANY LIMITED |
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| Manufacturer | BSP PHARMACEUTICALS S.P.A |
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| Country | ITALY |
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| Import Registration No | EU/1/11/678/001 |
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| Import Registration Date | 2011-03-17 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2023-08-21 |
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| FDD Registration No | 09 I 3897/13 |
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| FDD Registration Date | 2024-01-08 |
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| Expiry Date | 2027-01-07 |
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