View drug registration information details.
Items | Registration information |
ID | 656 |
No | 656 |
Brand Name | ROSWIN 5 MG TABLETS |
Ingredients | ROSUVASTATIN CALCIUM USP EQ.TO ROSUVASTATIN 5 MG |
Dosage Form | FILM COATED TABLET |
Primary Packaging | ALU-ALU BLISTER |
Storage | STORE BELOW 30 C |
Shelf Life | 36 MONTHS |
Pack Size | BOX OF 1 X 10'S |
Dispensing Category | Prescription only |
ATC Classification | |
Pharmaceutical Class | LIPID MODIFYING AGENTS |
Indications | • adjunctive therapy to diet to reduce elevated total cholesterol (total C), LDL, apolipoprotein B (ApoB), non-HDL, and TG levels and to increase HDL in adults with primary hyperlipidemia or mixed dyslipidemia.
• adjunctto reduce total C, LDL and ApoB levels in adolescents.
• Who are at least 1 year after menarchy (women), 10 to 17 years with heterozygous familial hypercholesterolemia (HeFH) and in those who, after dietary treatment, have an LDL >190mg/dl or.
• >160mg/dl and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
• For the treatment of hypertriglyceridemia in adults.
• For the treatment of primary dysbetalipoproteinemia (type III hyperlipoproteinemia).
•Adjunct therapy to other lipid-lowering treatments (e.g., LDL Apheresis) or alone if such treatments are not available to reduce LDL, total C, and ApoB in adults with hypercholesterolemia homozygous familial (HoFH).
• Adjunct to slow the progression of atherosclerosis in adults as
• Part of a treatment strategy aimed at lowering total C and LDL to target levels.
• Reduces the risk of myocardial infarction, stroke and artery Revascularization procedures in people at increased risk of cardiovascular disease. |
Contraindications | |
Side Effects | |
Unit Price | |
EDL |
Yes |
Description | Pink oval biconvex film coated tablet, engraved M/D on one side and plain from other side |
Note | ONLINE |
License Owner | EXAMED CO.,LTD |
Manufacturer | MARTIN DOW LTD |
Country | PAKISTAN |
Import Registration No | 48992 |
Import Registration Date | 2008-02-19 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2024-07-19 |
FDD Registration No | 01 I 5856/25 |
FDD Registration Date | 2025-01-23 |
Expiry Date | 2030-01-22 |
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