Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - bicalutamide lactose monohydrate sodium starch glycollate povidone k30 silica colloidalis anhydrica magnesium stearate - film coated tablet - 50 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - bicalutamide lactose monohydrate sodium starch glycollate povidone k30 silica colloidalis anhydrica magnesium stearate - film coated tablet - 150 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - bicalutamide lactose monohydrate sodium starch glycollate povidone k30 silica colloidalis anhydrica magnesium stearate - film coated tablet - 150 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - bicalutamide lactose monohydrate sodium starch glycollate povidone k30 silica colloidalis anhydrica magnesium stearate - film coated tablet - 50 milligram

Israel - English - Ministry of Health

teva israel ltd - bicalutamide - tablets - bicalutamide 150 mg - bicalutamide - bicalutamide - in patients with locally advanced prostate cancer (t3-t4 any n m0 t1-t2 n+ m0) bicalutamide is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. the management of patients with locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

Israel - English - Ministry of Health

inovamed ltd - bicalutamide - film coated tablets - bicalutamide 150 mg - bicalutamide - bicalutamide - in patients with locally advanced prostate cancer (t3 - t4 any n m0 t1 -t2 n+ m0), bicalutamide 150 mg is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. the management of patients with locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable

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)

physicians total care, inc. - 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 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 [see adverse reactions (6.2) ]. bicalutamide tablets have no indication for women, and should not be used in this population. bicalutamide tablets may cause fetal harm when administered to a pregnant woman. bicalutamide tablets are contraindicated in women, including those who are or may become pregnant. there are no studies in pregnant women using bicalutamide. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient sh

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