Imatinib-Teva

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Imatinib mesilate 477.877mg equivalent to imatinib 400 mg;  

Disponibil de la:

Teva Pharma (New Zealand) Limited

INN (nume internaţional):

Imatinib mesilate 477.877 mg (equivalent to imatinib 400 mg)

Dozare:

400 mg

Forma farmaceutică:

Film coated tablet

Compoziție:

Active: Imatinib mesilate 477.877mg equivalent to imatinib 400 mg   Excipient: Calcium hydrogen phosphate Crospovidone Magnesium stearate Opadry butterscotch 85F97369 Purified water

Tip de prescriptie medicala:

Prescription

Produs de:

PLIVA Croatia Ltd.

Indicații terapeutice:

- Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML) (for paediatric use see section 4.2). - Treatment of adult and paediatic patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section 4.2).

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/PE/PVC/Al foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, OPA/Al/PVC/Al foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PE/PVdC/PE/PVC/Al foil - 90 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, OPA/Al/PVC/Al foil - 90 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, HDPE with PP CRC - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, HDPE with PP CRC - 500 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture

Data de autorizare:

2017-08-03