View drug registration information details.
| Items | Registration information |
|---|
| ID | 116 |
|---|
| No | 116 |
|---|
| Brand Name | ROSETTA 10 |
|---|
| Ingredients | ROSUVASTATIN CALCIUM EQ.TO ROSUVASTATIN 10 MG |
|---|
| Dosage Form | FILM COATED TABLET |
|---|
| Primary Packaging | ALU-ALU BLISTER |
|---|
| Storage | STORE BELOW 30 C |
|---|
| Shelf Life | 24 MONTHS |
|---|
| Pack Size | BOX OF 10 X 10'S |
|---|
| Dispensing Category | PRESCRIPTION ONLY |
|---|
| ATC Classification | C10AA07 |
|---|
| Pharmaceutical Class | DYSLIPIDAEMIC AGENT |
|---|
| Indications | PREVENTION OF CARDIOVASCULAR EVENT, IN ADULT PATIENTS WITH HYPERCHOLESTEROLAEMIA, REDUCE TOTAL CHOLESTEROL, LDL-C AND APO B IN PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA IN CHILDREN AND ADOLESCENTS 6 TO 17 YEARS OF AGE |
|---|
| Contraindications | ACTIVE LIVER DISEASE, SEVERE RENAL IMPAIREMENT |
|---|
| Side Effects | DIZZINESS, HEADACHE,M DIABTE MELLITUS, CONSTIPATION, NAUSEA |
|---|
| Unit Price | |
|---|
| EDL |
No |
|---|
| Description | ROUND, CONVEX, PINK FILM COATED TABLET WITH BERLIN AND 10 ON ONE SIDE AND PLAIN ON THE OTHER SIDE |
|---|
| Note | |
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| License Owner | BERLIN PHARMA LAO CO.,LTD |
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| Manufacturer | BERLIN PHARMACEUTICAL INDUSTRY CO.,LTD |
|---|
| Country | THAILAND |
|---|
| Import Registration No | 1A 55/66 (NG) |
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| Import Registration Date | 2023-11-11 |
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| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2024-07-05 |
|---|
| FDD Registration No | 12 I 5816/24 |
|---|
| FDD Registration Date | 2024-12-16 |
|---|
| Expiry Date | 2029-12-15 |
|---|
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