View drug registration information details.
| Items | Registration information |
|---|
| ID | 1300 |
|---|
| No | 1300 |
|---|
| Brand Name | ZOTALINE |
|---|
| Ingredients | SERTRALINE HYDROCHLORIDE 55.95 MG EQ.TO SERTRALINE 50 MG |
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| Dosage Form | FILM-COATED TABLETS |
|---|
| Primary Packaging | BLISTERPACK |
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| Storage | |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 3 X10'S |
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| Dispensing Category | |
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| ATC Classification | |
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| Pharmaceutical Class | |
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| Indications | ZOTALINE IS INDICATED FOR THE TREATMENT AS FOLLOWS :
- SYMPTOMS OF DEPRESSION, INCLUDING DEPRESSION ACCOMPANIED BY SYMPTOMS OF ANXIETY, IN PATIENTS WITH OR WITHOUT A HISTORY OF MANIA. OBSESSIVE -COMPULSIVE DISORDER, PANIC DISORDER WITH OR WITHOUT AGORAPHOBIA, POST-TRAUMATIC STRESS ORDER, SOCIAL PHOBIA |
|---|
| Contraindications | |
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| Side Effects | |
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| Unit Price | |
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| EDL |
NULL |
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| Description | WHITE TO OFF WHITE, CAPSULE SHAPED AND FILM COATED TABLET ENGRAVED M&H ON ONE SIDE AND ZOT AND 50 WITH SCORE - LINE ON THE OTHER SIDE. |
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| Note | |
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| License Owner | KARNYA VIENGNAKORN EXPORT-IMPORT |
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| Manufacturer | M & H MANUFACTURING CO., LTD |
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| Country | THAILAND |
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| Import Registration No | |
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| Import Registration Date | |
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| Activity | STEP 1: RECEIVE (RENEW) |
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| Applied Date | 27-JUN-2025 |
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| FDD Registration No | 03 I 3768/12 |
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| FDD Registration Date | 26-SEP-2022 |
|---|
| Expiry Date | 25-SEP-2025 |
|---|
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