| ID | 538 |
|---|
| No | 538 |
|---|
| Brand Name | LEDVIR |
|---|
| Ingredients | LEDIPASVIR 90 MG, SOFOSBUVIR 400 MG |
|---|
| Dosage Form | FILM COATED TABLET |
|---|
| Primary Packaging | BOTTLE |
|---|
| Storage | DO NOT ABOVE 30C |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 28 TABLETS |
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| Dispensing Category | PRESCRIPTION |
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| ATC Classification | J05AP51 |
|---|
| Pharmaceutical Class | ANTIVIRAL |
|---|
| Indications | FOR THE TREATMENT OF CHRONIC HEPATITIS C IN ADULTS AND IN ADOLESCENT AGED 12 TO <18 YEARS. |
|---|
| Contraindications | HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE, CO-ADMINISTRATION WITH ROSUVASTATIN, USE WITH POTENT P-GP INDUCER |
|---|
| Side Effects | |
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| Unit Price | |
|---|
| EDL |
Yes |
|---|
| Description | LIGHTBLUE, OVAL SHAPED, BICONVEX, BEVELED EDGE FILM COATED TABLET DEBOSSED WITH "LSF" ON ONE SIDE OF THE TABLET AND " M" ON THE OTHER SIDE |
|---|
| Note | |
|---|
| License Owner | DKSH LAOS COMPANY LIMITED |
|---|
| Manufacturer | MYLAN LABORATORIES LIMITED |
|---|
| Country | INDIA |
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| Import Registration No | NKD89 |
|---|
| Import Registration Date | 2015-12-28 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2021-01-15 |
|---|
| FDD Registration No | 12 I 5343/22 |
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| FDD Registration Date | 2022-12-30 |
|---|
| Expiry Date | 2025-12-29 |
|---|
