View drug registration information details.
Items | Registration information |
ID | 151 |
No | 151 |
Brand Name | APOLETS |
Ingredients | CLOPIDOGREL BISULFATE 98 MG EQ TO CLOPIDROGREL 75 MG |
Dosage Form | FILM-COATED TABLETS |
Primary Packaging | BLISTERPACK |
Storage | STORE BELOW 25 C |
Shelf Life | 3 YEARS AFTER MANUFACTURE |
Pack Size | 3 X 10 'S/BOX |
Dispensing Category | Prescription only |
ATC Classification | B01AC04 |
Pharmaceutical Class | ANTITHROMBOTIC |
Indications | RECENT MI, RECENT STROKE OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE AND ACUTE CORONARY SYNDROME. |
Contraindications | HYPERSENSITIVITY TO THE DRUG SUBSTANCE OR ANY COMPONENT OF THE PRODUCT. ACTIVE PATHOLOGICAL BLEEDING SUCH AS PEPTIC ULCER OR INTRACRANIAL HEMORRHAGE. |
Side Effects | ADVERSE 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 |
Description | REDDISH BROWN, ROUND, BICONVEX, FILM COATED TABLETS,IMPRINTED '' APO'' ON ONE SIDE AND ''CL'' OVER''75'' ON THE OTHER SIDE |
Note | |
License Owner | BERLIN PHARMA LAO CO.,LTD |
Manufacturer | APOTEX INCORPORATED |
Country | THAILAND |
Import Registration No | 1C 61/51 (NG) |
Import Registration Date | 2008-12-29 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2022-08-19 |
FDD Registration No | 03 I 3712/12 |
FDD Registration Date | 2023-03-31 |
Expiry Date | 2026-03-30 |
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