View drug registration information details.
Items | Registration information |
ID | 520 |
No | 520 |
Brand Name | GLUCOVANCE 500 MG/5MG |
Ingredients | METFORMIN HYDROCHLORIDE 500 MG, GLIBENCLAMIDE 5 MG |
Dosage Form | FILM COATED TABLET |
Primary Packaging | PVC-PVDC BLISTER |
Storage | STORE BELOW 30 C |
Shelf Life | 3 YEARS |
Pack Size | BOX OF 30 TABLETS |
Dispensing Category | Prescription only |
ATC Classification | A10BD02 |
Pharmaceutical Class | ANTIDIABETE |
Indications | TREATMENT OF TYPE 2 DIABETES IN ADULT, AS REPLACEMENT FOR PREVIOUS COMBINATION THERAPY WITH METFORMIN AND GLIBENCAMIDE IN PATIENTS WHOSE GLYCAEMIA IS STABLE AND WELL-CONTROLLED. |
Contraindications | HYPERSENSITIVITY, TYPE 1 DIABETE, RENAL FAILURE OR RENAL DYSFUNCTION, ACUTE CONDITION WITH THE POTENTIAL TO ALTER RENAL FUNCTION SUCH AS: DYHYDRATION, SEVERE INFECTION, HEPATIC INSUFFICIENCY, ACUTE ALCOHOL INTOXICATION, ALCOHOLISM, PORPHYRIA, LACTATION |
Side Effects | TASTE DISTURBANCE, GI DISORDER SUCH AS NAUSEA, VIMITTING, DIARRHEA, ABDOMINAL PAIN AND LOSS OF APPETITE, PRURITUS, URTICARIA, MACULOPAPULAR RASH |
Unit Price | |
EDL |
No |
Description | YELLOW CAPSULE- SHAPED, BICONVEX FILM-COATED TABLET WITH ‘5’ ENGRAVED ON ONE SIDE |
Note | |
License Owner | DKSH LAOS COMPANY LIMITED |
Manufacturer | MERCK SANTE S.A.S |
Country | FRANCE |
Import Registration No | 358 028-0 |
Import Registration Date | 2001-10-18 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2024-02-14 |
FDD Registration No | 02 I 5048/21 |
FDD Registration Date | 2024-06-22 |
Expiry Date | 2027-06-21 |
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