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Items	Registration information
ID	131
No	131
Brand Name	ECOVASTIN 10
Ingredients	ATORVASTATIN CALCIUM USP EQ.TO ATORVASTATIN 10 MG
Dosage Form	FILM COATED TABLET
Primary Packaging	ALU-ALU BLISTER
Storage	STORE AT CONTROLLED ROOM TEMPERATURE 20 -25C
Shelf Life	2 YEARS
Pack Size	BOX OF 3 X 10'S
Dispensing Category	PRESCRIPTION
ATC Classification
Pharmaceutical Class	HMG-COA REDUCTASE INHIBITOR
Indications	IN THE TREATMENT FOR AS AN ADJUNCT TO DIET FOR REDUCTION OF ELEVATED TOTAL CHOLESTEROL (TOTA-C), LDL-CHOLESTEROL(LDL-C), APOLIPOPROTEIN B, AND TRIGLYCERIDES IN ADULT, ADOLESCENTS AND CHILDREN AGED 10 YEARS OR OLDER WITH PRIMARYHYPERCHOLESTEROLAEMIA INCLUDING FAMILIAL HYPERCHOLESTEROLAEMIA OR COMBINED HYPERLIPIDEMIA (CORRESPONDING TO TYPE IIA AND IIB OF THE FREDRICKSON CLASSIFIATION) WHEN RESPONSE TO DIET AND OTHER NONPHARMACOLOGICAL MEASURES IS INADEQUATE
Contraindications	HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR ANY EXCIPIENT, ACTIVE LIVER DISEASE OR UNEXPLAINED PERSISTENT ELEVATIONS OF SERUM TRASMINASE EXCEEDING 3 TIMES THE UPPER LIMITED OF NORMAL, DURING PREGNANCY
Side Effects	DIARRHEA, RUNNY OR STUFF NOSE, JOINT PAIN, INSOMNIA, URINARY TRACT INFECTION, NAUSEA, LOSS OF APPETITE, MUSCLE PAIN, LIMB PAIN, CHEST PAIN, MUSCLE ACHE, MUSCLE WEAKNESS OR LOSS OF MUSCLE STRNGTH
Unit Price
EDL	Yes
Description	WHITE COLOR, ROUND SHAPED, BICONVEX FILM COATED TABLET, PLAIN ON BOTH SIDE
Note
License Owner	ASA LAO SOLE COMPANY LIMITED
Manufacturer	IMPULSE PHARMA PVT.LTD
Country	INDIA
Import Registration No	KD/641 (FORM 25)
Import Registration Date	2019-11-26
Activity	CERTIFICATE RELEASED
Applied Date	2025-02-24
FDD Registration No	02 I 5187/22
FDD Registration Date	2025-03-03
Expiry Date	2030-03-02

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