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ItemsRegistration information
ID151
No151
Brand NameAPOLETS
IngredientsCLOPIDOGREL BISULFATE 98 MG EQ TO CLOPIDROGREL 75 MG
Dosage FormFILM-COATED TABLETS
Primary PackagingBLISTERPACK
StorageSTORE BELOW 25 C
Shelf Life3 YEARS AFTER MANUFACTURE
Pack Size3 X 10 'S/BOX
Dispensing CategoryPrescription only
ATC ClassificationB01AC04
Pharmaceutical ClassANTITHROMBOTIC
IndicationsRECENT MI, RECENT STROKE OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE AND ACUTE CORONARY SYNDROME.
ContraindicationsHYPERSENSITIVITY TO THE DRUG SUBSTANCE OR ANY COMPONENT OF THE PRODUCT. ACTIVE PATHOLOGICAL BLEEDING SUCH AS PEPTIC ULCER OR INTRACRANIAL HEMORRHAGE.
Side EffectsADVERSE EVENTS OCCURRING IN > 2.5% OF CLOPIDOGREL BISULFATE PATIENTS IN CAPRIE : CHEST PAIN, ACCIDENTAL INJURY, INFLUENZA - LIKE SYMPTOMS, PAIN,HEADACHE, DIZZINESS, ABDOMINAL PAIN, DYSPEPSIA.
Unit Price-
EDL Yes
DescriptionREDDISH BROWN, ROUND, BICONVEX, FILM COATED TABLETS,IMPRINTED '' APO'' ON ONE SIDE AND ''CL'' OVER''75'' ON THE OTHER SIDE
Note
License OwnerBERLIN PHARMA LAO CO.,LTD
ManufacturerAPOTEX INCORPORATED
CountryTHAILAND
Import Registration No1C 61/51 (NG)
Import Registration Date2008-12-29
ActivityCERTIFICATE RELEASED
Applied Date2022-08-19
FDD Registration No03 I 3712/12
FDD Registration Date2023-03-31
Expiry Date2026-03-30

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