View drug registration information details.
| Items | Registration information |
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| ID | 645 |
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| No | 645 |
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| Brand Name | ROSWIN 5 MG TABLETS |
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| Ingredients | ROSUVASTATIN CALCIUM USP EQ.TO ROSUVASTATIN 5 MG |
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| Dosage Form | FILM COATED TABLET |
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| Primary Packaging | ALU-ALU BLISTER |
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| Storage | |
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| Shelf Life | 36 MONTHS |
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| Pack Size | BOX OF 1 X 10'S |
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| Dispensing Category | |
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| ATC Classification | |
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| Pharmaceutical Class | |
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| 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. |
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| Contraindications | |
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| Side Effects | |
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| Unit Price | |
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| EDL |
NULL |
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| Description | Pink oval biconvex film coated tablet, engraved M/D on one side and plain from other side |
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| Note | |
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| License Owner | EXAMED CO.,LTD |
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| Manufacturer | MARTIN DOW LTD |
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| Country | PAKISTAN |
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| Import Registration No | |
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| Import Registration Date | |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | |
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| FDD Registration No | 01 I 5856/25 |
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| FDD Registration Date | 23-JAN-2025 |
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| Expiry Date | 22-JAN-2030 |
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