View drug registration information details.
Items | Registration information |
ID | 480 |
No | 480 |
Brand Name | CRYSTORVAS TABLET 40 MG |
Ingredients | ATORVASTATIN CALCIUM TRIHYDRATE( CRYSTALLINE) 44.40 MG EQ.TO ATORVASTATIN 40 MG |
Dosage Form | FILM COATED TABLET |
Primary Packaging | ALU-ALU PVC BLISTER |
Storage | STORE AT THE TEMPERATURE BELOW 30 C AND PROTECT FROM LIGHT |
Shelf Life | 2 YEARS |
Pack Size | BOX OF 3 X 10'S |
Dispensing Category | PRESCRIPTION |
ATC Classification | C10AA05 |
Pharmaceutical Class | ANTIHYPERCHOLESTEROLEMIA |
Indications | AS AN ADJUNCT TO DIET FOR THE TREATMENT OF PATIENTS WITH ELEVATED TOTAL CHOLESTEROL, LDL-CHOLESTEROL, APOLIPOPROTEIN B AND TRIGLYCERIDES AND TO INCREASE HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, COMBINED HYPERLIPIDEMIA (FREDRICKSON TYPES IIA AND IIB), ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDRICKSON TYPE IV) AND FOR PATIENTS WITH DYSBETALIPOPROTEINEMIA (FREDRICKSON TYPE III) WHO DO NOT RESPOND ADEQUATELY TO DIET |
Contraindications | HYPERSENSITIVITY, ACTIVE LIVER DISEASE OR UNEXPLAINED PERSISTENT ELEVATIONS OF SERUM TRANSAMINASE EXCEEDING 3 TIMES THE UPPER LIMIT OF NORMAL, DURING PREGNANCY, TREATED WITH THE HEPATITIS C ANTIVIRALS GLECAPREVIR/PIBRENTASVIR |
Side Effects | NASOPHARYNGITIS, ALLERGIC REACTION, HYPERGLYCAEMIA, HEADACHE, PHARYNGOLARYNGEAL PAIN, EPISTAXIS, CONSTIPATION, FLATULENCE, DYSPEPSIA, NAUSEA, DIARRHEA |
Unit Price | |
EDL |
Yes |
Description | WHITE TO OFF WHITE , 10 MM ROUND, BICONVEX, WITH " 40" MARKING ON ONE SIDE AND PLAIN ON THE OTHER SIDE, FILM COATED TABLET |
Note | |
License Owner | DKSH LAOS COMPANY LIMITED |
Manufacturer | DUOPHARMA MANUFACTURING(BANGI)SDN.BHD. |
Country | MALAYSIA |
Import Registration No | MAL20046120AZ |
Import Registration Date | 30-04-2020 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2022-03-30 |
FDD Registration No | 05 I 5514/23 |
FDD Registration Date | 2023-05-15 |
Expiry Date | 2026-05-14 |
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