View drug registration information details.
Items | Registration information |
ID | 423 |
No | 423 |
Brand Name | ATORWAN 10 |
Ingredients | ATORVASTATIN CALCIUM USP EQ.TO ATORVASTATIN 10 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 |
ATC Classification | C10AA05 |
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 | |
EDL |
Yes |
Description | WHITE TO OFF WHITE CIRCULAR SHAPED BICONVEX FILM COATED TABLETS WITH A BREAK LINE ON ONE SIDE |
Note | |
License Owner | DKSH LAOS COMPANY LIMITED |
Manufacturer | SUNRISE INTERNATIONAL LAB LTD. |
Country | INDIA |
Import Registration No | 7503/A3/2015 |
Import Registration Date | 2015-05-18 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2022-04-08 |
FDD Registration No | 01 I 5663/24 |
FDD Registration Date | 2024-01-26 |
Expiry Date | 2027-01-25 |
Back to drug list
|