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

alphapharm pty ltd - alprazolam, quantity: 0.25 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; sodium starch glycollate; docusate sodium; maize starch; lactose monohydrate; sodium benzoate; povidone - for short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. alprazolam is not recommended as primary therapy in patients with depression. for the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.indications as at 17 december 2001 : anxiety. short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. panic disorder. the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. the diagnostic criteria for panic disorder in dsm-iii-r are as follows: the panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. later in the course of this disturbance, certain situations (e.g. driving a car or being i

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

4 farmers australia pty ltd - sodium fluoroacetate - liquid concentrate - sodium fluoroacetate mineral-fluorine active 30.0 g/l - vertebrate poison

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 20 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 40 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 60 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - docetaxel - head and neck neoplasms, carcinoma, non-small-cell lung, adenocarcinoma, prostatic neoplasms, breast neoplasms - antineoplastic agents, - breast cancerdocetaxel accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.docetaxel accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.docetaxel accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer w

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

alphapharm pty ltd - alprazolam, quantity: 2 mg - tablet, uncoated - excipient ingredients: docusate sodium; sodium starch glycollate; povidone; maize starch; sodium benzoate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica - anxiety. short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. panic disorder. the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. the diagnostic criteria for panic disorder in dsm-iii-r are as follows: the panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. later in the course of this disturbance, certain situations (eg. driving a car or being in a crowded place) may become associated with having a panic attack. these panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). the diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. the panic attacks must be characterised by at least four of the following symptoms: dyspnoea or smothering sensations; dizziness, unsteady feelings or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalisation or derealisation; paraesthesiae; flushes (hot flashes) or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. note: attacks involving four or more symptoms are panic attacks; attacks involving fewer than four are limited symptom attacks. at least some of the panic attack symptoms must develop suddenly and increase in intensity within ten minutes of the beginning of the first symptom noticed in the attack. the panic attack must not be attributable to some known organic factor, eg. amphetamine or caffeine, intoxication, hyper-thyroidism. the efficacy of alprazolam in conditions where the above criteria are not met has not been established. the risk versus benefits of alprazolam use in milder disorders, which do not meet the above criteria, has not been evaluated. although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation. the results of a long-term study in patients taking alprazolam (ie. beyond three months) suggest that many patients continue to benefit from alprazolam therapy and that alprazolam efficacy is maintained for up to eight months. the physician should periodically reassess the usefulness of the drug for each patient. a comparative study of alprazolam and placebo in the treatment of panic attacks in patients with panic disorder involved 543 patients over an eight week period. alprazolam was significantly more effective than placebo in reducing the total number of panic attacks (p<0.0001); at week 4, 46.8% of alprazolam patients had achieved zero total panic attacks when compared to 27.1% of placebo patients. panic disorders are often severe, chronic illnesses that cause a high level of work and social disability, increased substance abuse and potentially increased morbidity and mortality. psychological and social factors are important in the pathogenesis of panic attacks, either acting alone or in combination with biological factors. prolonged pharmacological therapy may be used as an adjunct to psychosocial therapy in the treatment of patients with panic disorders.

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

alphapharm pty ltd - alprazolam, quantity: 1 mg - tablet, uncoated - excipient ingredients: sodium starch glycollate; maize starch; docusate sodium; colloidal anhydrous silica; magnesium stearate; sodium benzoate; lactose monohydrate; indigo carmine aluminium lake; microcrystalline cellulose; povidone - for short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. alprazolam is not recommended as primary therapy in patients with depression. for the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. indications as at 17 december 2001 : anxiety. short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. panic disorder. the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. the diagnostic criteria for panic disorder in dsm-iii-r are as follows: the panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. later in the course of this disturbance, certain situations (e.g. driving a car or being in a crowded place) may become associated with having a panic attack. these panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). the diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. the panic attacks must be characterised by at least four of the following symptoms: dyspnoea or smothering sensations; dizziness, unsteady feelings or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalisation or derealisation; paraesthesiae; flushes (hot flashes) or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. note. attacks involving four or more symptoms are panic attacks; attacks involving fewer than four are limited symptom attacks. at least some of the panic attack symptoms must develop suddenly and increase in intensity within ten minutes of the beginning of the first symptom noticed in the attack. the panic attack must not be attributable to some known organic factor, e.g. amphetamine or caffeine, intoxication, hyperthyroidism. the efficacy of alprazolam in conditions where the above criteria are not met has not been established. the risk versus benefits of alprazolam use in milder disorders, which do not meet the above criteria, has not been evaluated. although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation. the results of a long-term study in patients taking alprazolam (ie. beyond three months) suggest that many patients continue to benefit from alprazolam therapy and that alprazolam efficacy is maintained for up to eight months. the physician should periodically reassess the usefulness of the drug for each patient. a comparative study of alprazolam and placebo in the treatment of panic attacks in patients with panic disorder involved 543 patients over an eight week period. alprazolam was significantly more effective than placebo in reducing the total number of panic attacks (p < 0.0001); at week 4, 46.8% of alprazolam patients had achieved zero total panic attacks when compared to 27.1% of placebo patients. panic disorders are often severe, chronic illnesses that cause a high level of work and social disability, increased substance abuse and potentially increased morbidity and mortality. psychological and social factors are important in the pathogenesis of panic attacks, either acting alone or in combination with biological factors. prolonged pharmacological therapy may be used as an adjunct to psychosocial therapy in the treatment of patients with panic disorders.

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

alphapharm pty ltd - alprazolam, quantity: 0.5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; magnesium stearate; povidone; docusate sodium; colloidal anhydrous silica; indigo carmine aluminium lake; sodium starch glycollate; maize starch; erythrosine aluminium lake; lactose monohydrate; sodium benzoate - for short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. alprazolam is not recommended as primary therapy in patients with depression. for the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. indications as at 17 december 2001 : anxiety. short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. panic disorder. the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. the diagnostic criteria for panic disorder in dsm-iii-r are as follows: the panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. later in the course of this disturbance, certain situations (e.g. driving a car or being in a crowded place) may become associated with having a panic attack. these panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). the diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. the panic attacks must be characterised by at least four of the following symptoms: dyspnoea or smothering sensations; dizziness, unsteady feelings or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalisation or derealisation; paraesthesiae; flushes (hot flashes) or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. note. attacks involving four or more symptoms are panic attacks; attacks involving fewer than four are limited symptom attacks. at least some of the panic attack symptoms must develop suddenly and increase in intensity within ten minutes of the beginning of the first symptom noticed in the attack. the panic attack must not be attributable to some known organic factor, e.g. amphetamine or caffeine, intoxication, hyperthyroidism. the efficacy of alprazolam in conditions where the above criteria are not met has not been established. the risk versus benefits of alprazolam use in milder disorders, which do not meet the above criteria, has not been evaluated. although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation. the results of a long-term study in patients taking alprazolam (ie. beyond three months) suggest that many patients continue to benefit from alprazolam therapy and that alprazolam efficacy is maintained for up to eight months. the physician should periodically reassess the usefulness of the drug for each patient. a comparative study of alprazolam and placebo in the treatment of panic attacks in patients with panic disorder involved 543 patients over an eight week period. alprazolam was significantly more effective than placebo in reducing the total number of panic attacks (p < 0.0001); at week 4, 46.8% of alprazolam patients had achieved zero total panic attacks when compared to 27.1% of placebo patients. panic disorders are often severe, chronic illnesses that cause a high level of work and social disability, increased substance abuse and potentially increased morbidity and mortality. psychological and social factors are important in the pathogenesis of panic attacks, either acting alone or in combination with biological factors. prolonged pharmacological therapy may be used as an adjunct to psychosocial therapy in the treatment of patients with panic disorders.

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

alphapharm pty ltd - alprazolam, quantity: 0.25 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; sodium starch glycollate; docusate sodium; maize starch; lactose monohydrate; sodium benzoate; povidone - for short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. alprazolam is not recommended as primary therapy in patients with depression. for the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.indications as at 17 december 2001 : anxiety. short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. panic disorder. the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. the diagnostic criteria for panic disorder in dsm-iii-r are as follows: the panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. later in the course of this disturbance, certain situations (e.g. driving a car or being in a crowded place) may become associated with having a panic attack. these panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). the diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. the panic attacks must be characterised by at least four of the following symptoms: dyspnoea or smothering sensations; dizziness, unsteady feelings or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalisation or derealisation; paraesthesiae; flushes (hot flashes) or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. note. attacks involving four or more symptoms are panic attacks; attacks involving fewer than four are limited symptom attacks. at least some of the panic attack symptoms must develop suddenly and increase in intensity within ten minutes of the beginning of the first symptom noticed in the attack. the panic attack must not be attributable to some known organic factor, e.g. amphetamine or caffeine, intoxication, hyperthyroidism. the efficacy of alprazolam in conditions where the above criteria are not met has not been established. the risk versus benefits of alprazolam use in milder disorders, which do not meet the above criteria, has not been evaluated. although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation. the results of a long-term study in patients taking alprazolam (ie. beyond three months) suggest that many patients continue to benefit from alprazolam therapy and that alprazolam efficacy is maintained for up to eight months. the physician should periodically reassess the usefulness of the drug for each patient. a comparative study of alprazolam and placebo in the treatment of panic attacks in patients with panic disorder involved 543 patients over an eight week period. alprazolam was significantly more effective than placebo in reducing the total number of panic attacks (p < 0.0001); at week 4, 46.8% of alprazolam patients had achieved zero total panic attacks when compared to 27.1% of placebo patients. panic disorders are often severe, chronic illnesses that cause a high level of work and social disability, increased substance abuse and potentially increased morbidity and mortality. psychological and social factors are important in the pathogenesis of panic attacks, either acting alone or in combination with biological factors. prolonged pharmacological therapy may be used as an adjunct to psychosocial therapy in the treatment of patients with panic disorders.