New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - goserelin acetate 3.8mg equivalent to 3.6 mg goserelin;  ; bicalutamide 50mg;   - combination - 3.6mg + 50mg pack - active: goserelin acetate 3.8mg equivalent to 3.6 mg goserelin   excipient: polyglactin active: bicalutamide 50mg   excipient: hypromellose lactose macrogol 300 magnesium stearate povidone sodium starch glycolate titanium dioxide - zolacos cp is indicated for the treatment of advanced prostate cancer and prevention of disease flare associated with the use of lhrh agonists.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - goserelin acetate 12.5mg equivalent to 10.8 mg goserelin - subcutaneous implant - 10.8 mg - active: goserelin acetate 12.5mg equivalent to 10.8 mg goserelin excipient: poly(lactide) polyglactin - prostate cancer suitable for hormonal manipulation. adjuvant and neoadjuvant therapy in combination with radiotherapy for the management of locally advanced prostate cancer in men suitable for hormonal manipulation.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - goserelin acetate 11.34mg equivalent to 10.8 mg goserelin;  ; bicalutamide 50mg - combination - 10.8mg+50mg pack - active: goserelin acetate 11.34mg equivalent to 10.8 mg goserelin   excipient: polyglactin active: bicalutamide 50mg excipient: hypromellose lactose macrogol 300 magnesium stearate povidone sodium starch glycolate titanium dioxide - zolacos cp is indicated for the treatment of advanced prostate cancer and prevention of disease flare associated with the use of lhrh agonists.

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

astrazeneca uk ltd - goserelin acetate - prolonged-release subcutaneous implant - 10.8mg

United States - English - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - bicalutamide (unii: a0z3nau9dp) (bicalutamide - unii:a0z3nau9dp) - bicalutamide 50 mg - bicalutamide tablets, usp 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (lhrh) analog for the treatment of stage d2 metastatic carcinoma of the prostate. bicalutamide tablets, usp 150 mg daily are not approved for use alone or with other treatments [see clinical studies (14.2)]. bicalutamide tablets, usp are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see adverse reactions (6.2)] . bicalutamide tablets, usp have no indication for women, and should not be used in this population. bicalutamide tablets, usp may cause fetal harm when administered to a pregnant woman. bicalutamide tablets, usp are contraindicated in women, including those who are or may become pregnant. there are no studies in pregnant women using bicalutamide tablets, usp. if this drug is used during pregnancy, or if the pat

United States - English - NLM (National Library of Medicine)

dava pharmaceuticals, inc. - bicalutamide (unii: a0z3nau9dp) (bicalutamide - unii:a0z3nau9dp) - bicalutamide 50 mg - bicalutamide tablets, usp 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (lhrh) analog for the treatment of stage d2 metastatic carcinoma of the prostate. bicalutamide tablets, usp 150 mg daily are not approved for use alone or with other treatments [see clinical studies (14.2)]. bicalutamide tablets, usp are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see adverse reactions (6.2)] . bicalutamide tablets, usp have no indication for women, and should not be used in this population. bicalutamide tablets, usp may cause fetal harm when administered to a pregnant woman. bicalutamide tablets, usp are contraindicated in women, including those who are or may become pregnant. there are no studies in pregnant women using bicalutamide tablets, usp. if this drug is used during pregnancy, or if the pat

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - bicalutamide (unii: a0z3nau9dp) (bicalutamide - unii:a0z3nau9dp) - bicalutamide 50 mg - bicalutamide tablets 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (lhrh) analog for the treatment of stage d2 metastatic carcinoma of the prostate. bicalutamide tablets 150 mg daily are not approved for use alone or with other treatments [see clinical studies (14.2) ]. bicalutamide tablets are contraindicated in: - hypersensitivity bicalutamide tablets are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. hypersensitivity reactions including angioneurotic edema and urticaria have been reported. - women bicalutamide tablets have no indication for women, and should not be used in this population. - pregnancy bicalutamide tablets can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ]. risk summary bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. bicalutamide is not indicated for use in f

United States - English - NLM (National Library of Medicine)

northstar rxllc - bicalutamide (unii: a0z3nau9dp) (bicalutamide - unii:a0z3nau9dp) - bicalutamide 50 mg - bicalutamide 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (lhrh) analog for the treatment of stage d2 metastatic carcinoma of the prostate. bicalutamide 150 mg daily is not  approved for use alone or with other treatments [see clinical studies (14.2)] . bicalutamide is contraindicated in: -   hypersensitivity bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. hypersensitivity reactions including angioneurotic edema and urticaria have been reported. - women bicalutamide has no indication for women, and should not be used in this population. - pregnancy bicalutamide can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . risk summary bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. bicalutamide is not indicated for use in females. there are no human data on the use of bicalutamide

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

astrazeneca pty ltd - goserelin, quantity: 10.8 mg - implant - excipient ingredients: polyglactin - for the treatment of advanced prostate cancer. bicalutamide is also indicated for the prevention of disease flare associated with initial goserelin treatment

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

juno pharmaceuticals pty ltd - bicalutamide -