View drug registration information details.

Items	Registration information
ID	162
No	162
Brand Name	FIBRIL
Ingredients	FENOFIBRATE PELLETS 241.55 MG EQ.TO FENOFIBRATE 160 MG
Dosage Form	CAPSULE
Primary Packaging	ALU-PVC BLISTER
Storage	STORE BELOW 25C
Shelf Life	2 YEARS
Pack Size	10 TABS/BLIST., 3BLISTS/BOX
Dispensing Category	Prescription only
ATC Classification	XX
Pharmaceutical Class	CARDIAC DRUGS
Indications	HYPERCHOLESTEROLEMIA OR HYPERTRIGLYCERIDEMIA OR MIX (DYSLIPEMIA TYPE III, IIB, III, IV, AND V) IN PATIENTS WHO DO NOT RESPONSE TO DIET AND NON-PHARMACOLOGICAL INTERVENTIONS, ESPECIALLY FOR PATIENTS WHO HAVE ANY RISKS
Contraindications	HYPERSENSITIVITY TO FENOFIBRATE OR INGREDIENTS LISTED AT THE LEAFLET, PHOTOSENSITIVITY TO FENOFIBRATE OR KETOPROFEN, CHILDREN, PREGNANCY OR LACTATION, PATIENTS WHO HAVE GALLSTONES, HEPATIC OR RENAL DYSFUNCTION
Side Effects	DIGESTIVE DISTURBANCES E.G. ABDOMINAL PAIN, NAUSEA, VOMITING, DIARRHEA, DIGESTIVE DISCMFORTS; SKIN SYMPTOMS E.G. MUSCLE PAIN, MYOSITIS, MUSCLE CRAMP, MYASTHENIA; INCREASE ENZYME TRANSAMINASES LEVEL (MODERATE)
Unit Price	7THB/TAB
EDL	No
Description	CAPSULE NO.2 WITH OPAQUE LIGHT-BLUE BODY AND OPAQUE BLUE CAPS, EMBOSSED “BERLIN” ON THE CAP AND “F” ON THE BODY, CONTAINING WHITE GRANULES.
Note
License Owner	BERLIN PHARMA LAO CO.,LTD
Manufacturer	BERLIN PHARMACEUTICAL INDUSTRY CO., LTD.
Country	THAILAND
Import Registration No	1A 274/55
Import Registration Date	2012-07-24
Activity	CERTIFICATE RELEASED
Applied Date	2023-05-12
FDD Registration No	06 I 3091/08
FDD Registration Date	2023-07-17
Expiry Date	2026-07-16

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