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ItemsRegistration information
ID480
No480
Brand NameCRYSTORVAS TABLET 40 MG
IngredientsATORVASTATIN CALCIUM TRIHYDRATE( CRYSTALLINE) 44.40 MG EQ.TO ATORVASTATIN 40 MG
Dosage FormFILM COATED TABLET
Primary PackagingALU-ALU PVC BLISTER
StorageSTORE AT THE TEMPERATURE BELOW 30 C AND PROTECT FROM LIGHT
Shelf Life2 YEARS
Pack SizeBOX OF 3 X 10'S
Dispensing CategoryPRESCRIPTION
ATC ClassificationC10AA05
Pharmaceutical ClassANTIHYPERCHOLESTEROLEMIA
IndicationsAS 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
ContraindicationsHYPERSENSITIVITY, 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 EffectsNASOPHARYNGITIS, ALLERGIC REACTION, HYPERGLYCAEMIA, HEADACHE, PHARYNGOLARYNGEAL PAIN, EPISTAXIS, CONSTIPATION, FLATULENCE, DYSPEPSIA, NAUSEA, DIARRHEA
Unit Price
EDL Yes
DescriptionWHITE TO OFF WHITE , 10 MM ROUND, BICONVEX, WITH " 40" MARKING ON ONE SIDE AND PLAIN ON THE OTHER SIDE, FILM COATED TABLET
Note
License OwnerDKSH LAOS COMPANY LIMITED
ManufacturerDUOPHARMA MANUFACTURING(BANGI)SDN.BHD.
CountryMALAYSIA
Import Registration NoMAL20046120AZ
Import Registration Date30-04-2020
ActivityCERTIFICATE RELEASED
Applied Date2022-03-30
FDD Registration No05 I 5514/23
FDD Registration Date2023-05-15
Expiry Date2026-05-14

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