bladder cancer

Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.
La gemcitabine est indiquée dans le traitement du cancer de la vessie localement avancé ou métastatique, en association avec le cisplatine.
The CHMP required the MAH to reflect the target population (patients with advanced/metastatic bladder cancer) and the combination treatment with cisplatin in the harmonized indication.
Le CHMP a exigé du titulaire de l’autorisation de mise sur le marché qu’il examine la population cible (patients atteints d’un cancer avancé/métastatique de la vessie) et le traitement combiné avec le cisplatine dans l’indication harmonisée.
The CHMP considered the data submitted in support of the bladder cancer indication and noted that all the submitted studies were conducted in patients with locally advanced or metastatic bladder cancer.
Le CHMP a considéré que les données fournies corroboraient l’indication dans le traitement du cancer de la vessie et a relevé que toutes les études fournies ont été conduites sur des patients atteints d’un cancer de la vessie localement avancé ou métastatique.
It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer.
Il est indiqué dans le cancer de la vessie, le cancer du poumon avancé à grosses cellules, le cancer avancé du pancréas, le cancer du sein et le cancer des ovaires.
Bladder cancer Combination use The recommended dose for gemcitabine is 1000 mg/m2, given by 30-minute infusion.
Cancer de la vessie En association La dose recommandée de gemcitabine est de 1 000 mg/m² en perfusion intraveineuse de 30 minutes.
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