View drug registration information details.
Items | Registration information |
ID | 525 |
No | 525 |
Brand Name | HERCEPTIN 150MG |
Ingredients | TRASTUZUMAB 150MG |
Dosage Form | POWDER FOR SOLUTION FOR INFUSION |
Primary Packaging | VIAL |
Storage | STORE AT 2 C-8 C |
Shelf Life | 4 YEARS |
Pack Size | 150 MG/VIAL/BOX |
Dispensing Category | Prescription only |
ATC Classification | XX |
Pharmaceutical Class | ANTINEOPLASTICS |
Indications | METASTATIC BREAST CANCER AS MONOTHERAPY OR IN COMBINATION WITH PACLITAXEL OR DOCETAXEL OR AROMATASE INHIBITOR;- EARLY BREAST CANCER FOLLOWING SURGERY, CHEMOTHERAPY AND RADIOTHERAPY; ADVANCED GASTRIC CANCER IN COMBINATION WITH CAPECITABINE OR INTRAVENOUS 5 FLUOROURACIL AND PLATINUM AGENT. |
Contraindications | KNOWN HYPERSENSITIVITY TO TRASTUZUMAB OR TO ANY OTHER COMPONENT OF THE PRODUCT |
Side Effects | FEVER AND CHILLS, ABDOMINAL PAIN, ASTHENIA, CHEST PAIN, HEADACHE, DIARRHEA, NAUSEA, VOMITING |
Unit Price | - |
EDL |
No |
Description | WHITE TO PALE YELLOW LYOPHILIZED CAKE GIVES CLEAR TO SLIGHTLY OPALESCENT LIQUID, COLORLESS AFTER RECONSTITUTION |
Note | |
License Owner | DKSH LAOS COMPANY LIMITED |
Manufacturer | ROCHE DIAGNOSTICS GMBH |
Country | SWITZERLAND |
Import Registration No | 55'065 02 |
Import Registration Date | 2014-02-07 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2024-08-08 |
FDD Registration No | 07 I 2316/04 |
FDD Registration Date | 2024-09-25 |
Expiry Date | 2029-09-24 |
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