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Zytiga 250 mg tablets
2015-09-26 10:29:36 来源: 作者: 【 】 浏览:614次 评论:0
1. Name of the medicinal product

ZYTIGA 250 mg tablets

2. Qualitative and quantitative composition

Each tablet contains 250 mg of abiraterone acetate.

Excipients with known effect: Each tablet contains 189 mg of lactose and 6.8 mg of sodium.

For the ull list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet.

White to off-white oval tablets, debossed with AA250 on one side.

4. Clinical particulars
 
4.1 Therapeutic indications

ZYTIGA is indicated with prednisone or prednisolone for:

• the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)

• the treatment of metastatic castration resistant prostate cancer in adult men whose disease has p

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