ATC Code

N07BA01  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

 

Product Description

NILOTINIB 200MG A4-3031 TASIGNA 200MG CAPSULES "EACH CAPSULE CONTAINS NILOTINIB BASE (AS HYDROCHLORIDE, MONOHYDRATE). CAPSULE CONTENT: LACTOSE MONOHYDRATE; CROSPOVIDONE; POLOXAMER; SILICA COLLOIDAL, ANHYDROUS/COLLOIDAL SILICON DIOXIDE; MAGNESIUM STEARATE CAPSULE SHELL: GELATIN; TITANIUM DIOXIDE (E ); IRON OXIDE, YELLOW (E ) PRINTING INK: SHELLAC; DEHYDRATED ALCOHOL; ISOPROPYL ALCOHOL; BUTYL ALCOHOL; PROPYLENE GLYCOL; STRONG AMMONIA SOLUTION; POTASSIUM HYDROXIDE; TITANIUM DIOXIDE; INDUSTRIAL METHYLATED SPIRIT; IRON OXIDE, RED (E" ANTINEOPLASTIC AND ADJUVANTS ORAL " 200 MG " CAPSULE PRESCRIPTION ONLY MEDICINE (POM) "TASIGNA HARD CAPSULES ARE INDICATED FOR THE: ? TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE. PATIENTS WHO HAVE BEEN TREATED WITH TASIGNA FOR AT LEAST 3 YEARS AND HAVE ACHIEVED A SUSTAINED DEEP MOLECULAR RESPONSE MAY BE ELIGIBLE FOR TREATMENT DISCONTINUATION (SEE SECTIONS DOSAGE REGIMEN AND ADMINISTRATION AND CLINICAL STUDIES) ? TREATMENT OF CHRONIC PHASE AND ACCELERATED PHASE PHILADELPHIA CHROMOSOME POSITI" NOVARTIS NIGERIA LIMITED NIGERIA NOVARTIS PHARMA STEIN AG SWITZERLAND 2021-05-28 2026-05-27

Manufacturer Name

Novartis Pharma Stein AG

Manufacturer Country

SWITZERLAND  

Approval Date

2021-05-28  

Expiry Date

2026-05-27