View drug registration information details.
| Items | Registration information |
|---|
| ID | 97 |
|---|
| No | 97 |
|---|
| Brand Name | BROMALEX |
|---|
| Ingredients | BROMAZEPAM 6 MG |
|---|
| Dosage Form | TABLET |
|---|
| Primary Packaging | BLISTERPACK |
|---|
| Storage | STORE BELOW 30 C |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 3 X 10'S |
|---|
| Dispensing Category | Prescription only |
|---|
| ATC Classification | N05BA08 |
|---|
| Pharmaceutical Class | ANXIOLYTIC |
|---|
| Indications | SYMPTOMATIC TREATMENT OF SEVERE AND/OR DISABLING ANXIETY, PREVENTION AND TREATMENT OF DELIRIUM TREMENS AND OTHER MANIFESTATION OF ALCOHOL WITHDRAWAL |
|---|
| Contraindications | ALLERGY, SEVERE RESPIRATORY FAILURE, SLEEP APNEA SYNDROME, SEVERE LIVER DISEASE, MYASTHENIA |
|---|
| Side Effects | ANGIOEDEMA, ANAPHYLACTIC SHOCK, CONFUSION STATE, AFFECTIVE DISORDER, DROWSINESS, HEADACHE, DIZZINESS, DIPLOPIA, HEART FAILURE, NAUSEA, VOMITTING, CONSTIPATION, RASH, PRURITUS, FATIGUE |
|---|
| Unit Price | - |
|---|
| EDL |
Yes |
|---|
| Description | WHITE, OBLONG, BICONVEX TABLET, WITH THREE BREAKABLE LINES ON BOTH SIDES. |
|---|
| Note | |
|---|
| License Owner | ARAVANH PHARMA SOLE CO.,LTD |
|---|
| Manufacturer | PHARMA PRODUCT MANUFACTURING (PPM) |
|---|
| Country | CAMBODIA |
|---|
| Import Registration No | CAM R2 0519LP-08 |
|---|
| Import Registration Date | 2018-04-10 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2022-10-05 |
|---|
| FDD Registration No | 08 I 4765/19 |
|---|
| FDD Registration Date | 2023-04-19 |
|---|
| Expiry Date | 2026-04-18 |
|---|
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