View drug registration information details.
| Items | Registration information |
|---|
| ID | 72 |
|---|
| No | 72 |
|---|
| Brand Name | OTAGIL10 |
|---|
| Ingredients | ROSUVASTATIN CALCIUM 10.417 MG EQ TO ROSUVASTATIN 10 MG |
|---|
| Dosage Form | FILM COATED TABLET |
|---|
| Primary Packaging | ALU-ALU |
|---|
| Storage | STORE AT TEMPERATURE NOT MORE THAN 30 C |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 3 X 10'S |
|---|
| Dispensing Category | PRESCRIPTION ONLY |
|---|
| ATC Classification | C10AA07 |
|---|
| Pharmaceutical Class | LIPID MODIFYING AGENT |
|---|
| Indications | TREATMENT OF HYPERCHOLESTEROLEMIA AND PREVENTION OF CARDIOVASCULAR EVENT |
|---|
| Contraindications | HYPERSENSITIVITY, ACTIVE LIVER DISEASE INCLUDING UNEXPLAINED, PERSISTENT ELEVATIONS OF SERUM TRANSMINASE, PATIENT WITH SEVERE RENAL IMPAIREMENT, IN PATIENTS WITH MYOPATHY, IN PATIENT RECEIVING CONMITANT COCLOSPORIN, DURING PRENANCY AND LACTATION |
|---|
| Side Effects | DIABETES MELLITUS, HEADACHE, DIZZINESS, CONSTIPATION, NAUSEA, ABDOMINAL PAIN, MYALGIA, ASTENIA |
|---|
| Unit Price | 900 B |
|---|
| EDL |
No |
|---|
| Description | PINK, ROUND, BICONVEX, FILM COATED TABLET WITH ENGRAVED RSV AND 10 ON ONE SIDE AND PLAIN ON THE OTHER SIDE |
|---|
| Note | |
|---|
| License Owner | AI KEN PHARMA CO., LTD |
|---|
| Manufacturer | UNISON LABORATORIES CO., LTD |
|---|
| Country | THAILAND |
|---|
| Import Registration No | 1A 27/62 (NG) |
|---|
| Import Registration Date | 2019-07-10 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2021-11-05 |
|---|
| FDD Registration No | 03 I 5427/23 |
|---|
| FDD Registration Date | 2023-03-31 |
|---|
| Expiry Date | 2026-03-30 |
|---|
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