| ID | 571 |
|---|
| No | 571 |
|---|
| Brand Name | NEPEXTO 50 ML/ML |
|---|
| Ingredients | ETANERCEPT (R-DNA ORIGIN) 50 MG/ML |
|---|
| Dosage Form | SOLUTION FOR INJECTION |
|---|
| Primary Packaging | PRE-FILLED SYRINGE, PRE-FILLED PEN |
|---|
| Storage | STORE AT 2-8C |
|---|
| Shelf Life | 2 YEARS |
|---|
| Pack Size | 1 ML SINGLE USE PRE-FILLED SYRINGE, 1 ML SINGLE USE PRE-FILLED PEN |
|---|
| Dispensing Category | Prescription only |
|---|
| ATC Classification | L04AB01 |
|---|
| Pharmaceutical Class | ANTINEOPLASTIC |
|---|
| Indications | RHEUMATOID ARTHRITIS, JUVENILE IDIOPATHIC ARTHRITIS, PSORIATIC ARTHRITIS, AXIAL SPONDYLOARTHRITIS |
|---|
| Contraindications | HYPERSENSITIVITY, SEPSIS OR RISK OF SEPSIS, ACTIVE INFECTION INCLUDNG CHRONIC ORLOCALIZED INFECTION |
|---|
| Side Effects | SITE REACTION, INFECTION, BRONCHITIS BLADDER INFECTION, SKIN INFECTION, |
|---|
| Unit Price | |
|---|
| EDL |
No |
|---|
| Description | CLEAR, SLIGHTLY OPALESCENT, COLORLESS OR PALE YELLOW SOLUTION |
|---|
| Note | |
|---|
| License Owner | DKSH LAOS COMPANY LIMITED |
|---|
| Manufacturer | LUPIN LIMITED(BIOTECH DIVISION) |
|---|
| Country | INDIA |
|---|
| Import Registration No | PDVACC12 (FORM 28D) |
|---|
| Import Registration Date | 2019-07-22 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 03-FEB-20222 |
|---|
| FDD Registration No | 07 I 5561/23 |
|---|
| FDD Registration Date | 2023-07-07 |
|---|
| Expiry Date | 2026-07-06 |
|---|
