View drug registration information details.
Items | Registration information |
ID | 674 |
No | 674 |
Brand Name | OESTROGEL 0.06 % |
Ingredients | ESTRADIOL HEMIHYDRATE( EXPRESSED IN ANHYDROUS ESTRADIOL) 60 MG/100G |
Dosage Form | GEL |
Primary Packaging | TUBE |
Storage | STORE BELOW 30 C |
Shelf Life | 3 YEARS |
Pack Size | BOX OF 80 G/TUBE |
Dispensing Category | Prescription only |
ATC Classification | G03CA03 |
Pharmaceutical Class | OESTROGEN |
Indications | CORRECTION OF ESTROGEN DEFICIENCY AND SYMPTOMS DUE TO ESTROGEN DEFICIENCY. ESPECIALLY THOSE RELATED TO NATURAL OR ARTIFICIAL MENOPAUSE, VASOMOTOR SYMPTOMS( HOT FLUSHES, NIGHT SWEATS), GENITO-URINARY TROPHIC SYMPTOMS AND PSYCHOLOGICAL SYMPTOMS, PREVENTION OF POST MENOPAUSAL BONE LOSS |
Contraindications | CURRENT VENOUS THROMBO-EMBOLIC DISEASE, RECENT ARTERIAL THROMBOTIC DISEASE, UNDIAGNOSED VAGIANAL BLEEDING, SEVERE HEPATIC DISEASE, HYPERSENSITIVITY, EMBOLIC CARDIAC DISEASE |
Side Effects | CARDIOVASCULAR OR THROMBO EMBOLIC ACCIDENT, CHOLESTERIC JAUNDICE, BENIGN MASTOPATHY, UTERINE TUMOUR., HEPATIC ADENOMA, GALACTORRHOEA, NAUSEA, VOMITTING, ABDOMINAL CRAMPS, FLATULENCE |
Unit Price | 4.07 |
EDL |
No |
Description | ALUMINIUM TUBE CONTAINING A TRANSPARENT GEL, COLORLESS ALCOHOL ODOR |
Note | |
License Owner | EXAMED CO.,LTD |
Manufacturer | BESINS MANUFACTURING BELGIUM |
Country | BELGIUM |
Import Registration No | BE111544 |
Import Registration Date | 28/11/1978 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2023-08-31 |
FDD Registration No | 10 I 4995/20 |
FDD Registration Date | 2024-01-08 |
Expiry Date | 2027-01-07 |
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