View drug registration information details.
| Items | Registration information |
|---|
| ID | 424 |
|---|
| No | 424 |
|---|
| Brand Name | ATORWAN 20 |
|---|
| Ingredients | ATORVASTATIN CALCIUM USP EQ.TO ATORVASTATIN 20 MG |
|---|
| Dosage Form | FILM COATED TABLET |
|---|
| Primary Packaging | ALU-ALU BLISTER PACK |
|---|
| Storage | STORE IN A COOL, DRY, AND DARK PLACE, BELOW 30C |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 10 X 10'S |
|---|
| Dispensing Category | Prescription only |
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| ATC Classification | C10AA05 |
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| Pharmaceutical Class | LIPID MODIFYING AGENTS |
|---|
| Indications | AS AN ADJUNCT TO DIET FOR REDUCTION OF ELEVATED TOTAL CHOLESTEROL (TOTAL -C), LDL-CHOLESTEROL (LDL-C), APOLIPOPROTEIN B AND TRIGLYCERIDE IN ADULTS, ADOLESCENTS AND CHILDREN AGED 10 YEARS OR OLDER WITH PRIMARY HYPERCHOLESTEROLAEMIA OR COMBINED HYPERLIPIDAEMIA WHEN RESPONSE TO DIET AND OTHER NONPHARMACOLOGICAL MEASURES IS INADEQUATE. |
|---|
| Contraindications | HYPERSENSITIVITY TO API OR EXCIPIENT, ACTIVE LIVER DISEASE, DURING PREGNANCY, WHILE BREAST-FEEDING |
|---|
| Side Effects | SWELLING OF THE FACE, TONGUE AND THROAT, SERIOUS ILLNESS WITH SEVERE PEELING AND SELLING OF THE SKIN, BLISTERING OF THE SKIN, MOUTH, EYES, GENITAL AND FEVER |
|---|
| Unit Price | |
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| EDL |
Yes |
|---|
| Description | WHITE TO OFF WHITE CIRCULAR SHAPED BICONVEX FILM COATED TABLETS WITH A BREAK LINE ON ONE SIDE |
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| Note | |
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| License Owner | DKSH LAOS COMPANY LIMITED |
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| Manufacturer | SUNRISE INTERNATIONAL LAB LTD. |
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| Country | INDIA |
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| Import Registration No | 7503/A3/2015 |
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| Import Registration Date | 2015-05-18 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2022-04-08 |
|---|
| FDD Registration No | 01 I 5664/24 |
|---|
| FDD Registration Date | 2024-01-26 |
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| Expiry Date | 2027-01-25 |
|---|
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