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CIPLA MEDROXYPROGESTERONE, DEPROCIP, MEDPROCIP (Cipla Australia Pty Ltd)

Product name
CIPLA MEDROXYPROGESTERONE, DEPROCIP, MEDPROCIP
Sponsor
Cipla Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
145 working days (255)
Active ingredients
medroxyprogesterone acetate
Registration type
New generic medicine
Indication

CIPLA MEDROXYPROGESTERONE, DEPROCIP, MEDPROCIP (suspension for injection) are indicated for:

Carcinoma

Palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma.

Endometriosis

For use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful.

Contraception (ovulation suppression)

For long-term prevention of pregnancy in women when administered at 3-month intervals.

Since loss of bone mineral density (BMD) may occur in pre-menopausal women, who use medroxyprogesterone acetate long-term (greater than 2 years), women should be assessed before starting treatment for contraception or endometriosis, for the risk of osteoporosis. Women under the age of 18 years may be at risk of failing to achieve their predicted peak BMD.

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