Imatinib-Teva

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

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Werkstoffen:

Imatinib mesilate 477.877mg equivalent to imatinib 400 mg;  

Beschikbaar vanaf:

Teva Pharma (New Zealand) Limited

INN (Algemene Internationale Benaming):

Imatinib mesilate 477.877 mg (equivalent to imatinib 400 mg)

Dosering:

400 mg

farmaceutische vorm:

Film coated tablet

Samenstelling:

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

Prescription-type:

Prescription

Geproduceerd door:

PLIVA Croatia Ltd.

therapeutische indicaties:

- 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).

Product samenvatting:

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

Autorisatie datum:

2017-08-03

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