Israel - English - Ministry of Health

tec-o-pharm-libra ltd - chlormadinone acetate; ethinylestradiol - film coated tablets - ethinylestradiol 0.03 mg; chlormadinone acetate 2 mg - etynodiol and estrogen - etynodiol and estrogen - oral hormonal contraceptive.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarian neoplasms - antineoplastic agents - ovarian cancerlynparza is indicated as monotherapy for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5.1).breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). patients with hormone receptor (hr)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.1).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lupin healthcare (uk) ltd - levonorgestrel - oral tablet - 1.5mg

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate - indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.,estelle-35ed will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications),if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, sugar coated - excipient ingredients: macrogol 6000; lactose monohydrate; sucrose; povidone; purified talc; calcium carbonate; glycol montanate; maize starch; magnesium stearate - juliet-35 ed is indicated for: the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. juliet-35 will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications).,if the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis. the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. juliet-35 ed will also provide effective oral contraception in this patient gr

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, sugar coated - excipient ingredients: maize starch; calcium carbonate; purified talc; sucrose; glycol montanate; macrogol 6000; povidone; lactose monohydrate; magnesium stearate; glyceryl montanate - brenda-35 ed is indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.,brenda-35 ed will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications).,if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (i.e. androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - nafarelin, quantity: 2 mg/ml - spray, solution - excipient ingredients: benzalkonium chloride; sorbitol; glacial acetic acid; hydrochloric acid; purified water; sodium hydroxide - indications as at 31 august 1995. synarel is indicated for the hormonal management of visually proven endometriosis, including pain relief and reduction of endometriotic lesions and for use in controlled ovarian stimulation programmes prior to in-vitro fertilisation, under the supervision of an infertility specialist.

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, sugar coated - excipient ingredients: povidone; calcium carbonate; maize starch; sucrose; lactose monohydrate; macrogol 6000; purified talc; magnesium stearate; glycol montanate - diane-35 ed is indicated for: the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. diane-35 will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications).,if the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for injection - trastuzumab 600 mg / 5 ml - trastuzumab - breast cancermetastatic breast cancerherceptin is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancerherceptin is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) . - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. - in combination with neoadjuvant chemotherapy followed by adjuvant herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameterherceptin should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay .

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - zoledronic acid as monohydrate - concentrate for solution for infusion - zoledronic acid as monohydrate 4 mg - zoledronic acid - treatment of hypercalcaemia of malignancy. treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors , in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy.