View drug registration information details.
| Items | Registration information |
|---|
| ID | 663 |
|---|
| No | 663 |
|---|
| Brand Name | ANDROGEL 50 MG |
|---|
| Ingredients | TESTOSTERONE 0.050 G |
|---|
| Dosage Form | GEL |
|---|
| Primary Packaging | SACHET |
|---|
| Storage | DO NOT REQUIRE ANY SPECIAL STORAGE CONDITION |
|---|
| Shelf Life | 36 MONTHS |
|---|
| Pack Size | 30 SACHETS X 5G/BOX |
|---|
| Dispensing Category | Prescription only |
|---|
| ATC Classification | G03BA03 |
|---|
| Pharmaceutical Class | HORMONE |
|---|
| Indications | REPLACEMENT THERAPY FOR MALE HYPOGONADISM, WHEN TESTOSTERONE DEFICIENCY HAS BEEN CONFIRMED BY CLINICAL FEATURES AND BIOCHEMICAL TESTS |
|---|
| Contraindications | IN CASE OF KNOWN OR SUSPECTED PROSTATIC CANCER OR BREAST CARCINOMA, HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR ANY OF THE EXCIPIENTS |
|---|
| Side Effects | MOOD DISORDERS, DIZZINESS, PARAESTHESIA, AMNESIA, HYPERAESTHESIA, HYPERTENTION, DIARRHEA, ALOPECIA, URTICARIA, HEADACHE, |
|---|
| Unit Price | - |
|---|
| EDL |
Yes |
|---|
| Description | TRANSPARENT GEL OR SLIGHTLY OPALESCENT, COLORLESS, ALCOHOL SMELL |
|---|
| Note | |
|---|
| License Owner | EXAMED CO.,LTD |
|---|
| Manufacturer | BESINS MANUFACTURING BELGIUM |
|---|
| Country | BELGIUM |
|---|
| Import Registration No | BE248437 |
|---|
| Import Registration Date | 2003-02-17 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 13/6/2024 |
|---|
| FDD Registration No | 10 I 3585/11 |
|---|
| FDD Registration Date | 2024-07-09 |
|---|
| Expiry Date | 2027-07-08 |
|---|
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