| ID | 560 |
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| No | 560 |
|---|
| Brand Name | MIRCERA 100 MCG/0.3 ML |
|---|
| Ingredients | METHOXY POLYETHYLENE GLYCOL EPOETIN BETA.0.100 MG/0.3 ML |
|---|
| Dosage Form | SOLUTION FOR INJECTION |
|---|
| Primary Packaging | PRE-FILLED SYRINGE |
|---|
| Storage | STORE AT 2-8'C,DO NOT FREEZE,KEEP SYRINGES IN THE OUTER CARTON |
|---|
| Shelf Life | 36 MONTHS |
|---|
| Pack Size | 1 PRE-FILLED SYRINGE/BOX |
|---|
| Dispensing Category | Prescription only |
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| ATC Classification | B03BA03 |
|---|
| Pharmaceutical Class | ANTIANEMICS/PRE & POST NATAL VITAMINS |
|---|
| Indications | FOR THE TREATMENT OF ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE ( CKD ) INCLUDING PATIENTS ON DIALYSIS AND PATIENTS NOT DIALYSIS |
|---|
| Contraindications | MIRCERA IS CONTRAINDICATED IN PATIENTS WITH UNCONTROLLED HYPERTENSION OR KNOWN HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR ANY OF THE EXCIPIENTS |
|---|
| Side Effects | HYPERTENSION,VASCULAR ACCESS THROMBOSIS,HEADACHE,HYPERSENSITIVITY,RASH( SEE PACK INSERT FOR MORE DETAILS ) |
|---|
| Unit Price | - |
|---|
| EDL |
No |
|---|
| Description | CLEAR, COLORLESS TO SLIGHTLY YELLOWISH LIQUID, PRACTICALLY FREE FROM PARTICLES |
|---|
| Note | |
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| License Owner | DKSH LAOS COMPANY LIMITED |
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| Manufacturer | F.HOFFMANN-LA ROCHE LTD |
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| Country | SWITZERLAND |
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| Import Registration No | 57860 03 |
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| Import Registration Date | 2012-03-30 |
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| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2024-08-08 |
|---|
| FDD Registration No | 01 I 3483/11 |
|---|
| FDD Registration Date | 2024-09-25 |
|---|
| Expiry Date | 2029-09-24 |
|---|
