| ID | 662 |
|---|
| No | 662 |
|---|
| Brand Name | ANDROGEL 16.2 MG/G |
|---|
| Ingredients | TESTOSTERONE 1.62 MG/100G |
|---|
| Dosage Form | GEL |
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| Primary Packaging | CANISTER |
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| Storage | STORE BELOW 30 C |
|---|
| Shelf Life | 36 MONTHS |
|---|
| Pack Size | 1 CONTAINER/CARTON, PACKS OF 1,2,3, 6 CONTAINERS |
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| Dispensing Category | Prescription only |
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| ATC Classification | G03BA03 |
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| Pharmaceutical Class | ANDROGEN |
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| Indications | IN ADULTS AS REPLACEMENT THERAPY FOR MALE HYPOGONADISM WHEN TESTOSTERONE DEFICIENCY HAS BEEN CLINICALLY AND BIOLOGICALLY CONFIRMED |
|---|
| Contraindications | IN CASE OF CONFIRMED OR SUSPECTED PROSTATE CANCER OR BREAST CARCINOMA, IN CASE OF HYPERSENSITIVITY TO API |
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| Side Effects | PSYCHIATRIC DISORDER AND SKIN REACTION |
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| Unit Price | |
|---|
| EDL |
No |
|---|
| Description | TRANSPENT OR SLIGHTLY OPALESCENT COLORLESS GEL |
|---|
| Note | |
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| License Owner | EXAMED CO.,LTD |
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| Manufacturer | LABORATOIRE BESINS INTERNATIONAL |
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| Country | FRANCE |
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| Import Registration No | 34009 300 537 0 6 |
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| Import Registration Date | 2016-05-09 |
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| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2023-08-03 |
|---|
| FDD Registration No | 04 I 5731/24 |
|---|
| FDD Registration Date | 26/4/2024 |
|---|
| Expiry Date | 25/4/2027 |
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