View drug registration information details.
| Items | Registration information |
|---|
| ID | 1084 |
|---|
| No | 1084 |
|---|
| Brand Name | ROSMI 10 |
|---|
| Ingredients | ROSUVASTATIN CALCIUM PH.EUR EQ.TO ROSUVASTATIN 10 MG |
|---|
| Dosage Form | FILM COATED TABLET |
|---|
| Primary Packaging | ALU-ALU BLISTER |
|---|
| Storage | STORE BELOW 30 C |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 3 X 10'S |
|---|
| Dispensing Category | Prescription only |
|---|
| ATC Classification | C10AA07 |
|---|
| Pharmaceutical Class | HMG-COA REDUCTASE |
|---|
| Indications | TREATMENT OF HYPERCHOLESTEROLAEMIA, PREVENTION OF CARDIOVASCULAR EVENTS |
|---|
| Contraindications | HYPERSENSITIVITY, ACTIVE LIVER DISEASE, SEVERE RENAL IMPAIRMENT, MYOPATHY, CONCOMITANT WITH CICLOSPORIN, DURING PREGNANCY AND LACTATION |
|---|
| Side Effects | DIABETE MELLITUS, HEADACHE, DIZZINESS, CONSTIPATION, NAUSEA, ABDOMINAL PAIN, MYALGIA, ASTHENIA |
|---|
| Unit Price | |
|---|
| EDL |
No |
|---|
| Description | PINK ROUND, BICONVEX, FILM COATED TABLETS, DEBOSSED WITH " C10" ON ONE SIDE AND PLAIN ON THE OTHER SIDE |
|---|
| Note | |
|---|
| License Owner | IC Pharma Lao Co., Ltd |
|---|
| Manufacturer | CADILA PHARMACEUTICALS LIMITED |
|---|
| Country | INDIA |
|---|
| Import Registration No | MFG/CADILA/16783/B |
|---|
| Import Registration Date | 2018-02-14 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2021-12-10 |
|---|
| FDD Registration No | 03 I 5407/23 |
|---|
| FDD Registration Date | 2023-03-17 |
|---|
| Expiry Date | 2026-03-16 |
|---|
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