Israel - inglês - Ministry of Health

j-c health care ltd - cobicistate; darunavir as ethanolate - film coated tablets - cobicistate 150 mg; darunavir as ethanolate 800 mg - darunavir - rezolsta is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v).שינוי משטר מינון 2/4/2019pregnancy and postpartumtreatment with rezolsta during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). therefore, therapy with rezolsta should not be initiated during pregnancy, and women who become pregnant during therapy with rezolsta should be switched to an alternative regimen, see section 4.4 and 4.6. darunavir/ritonavir may be considered as an alternative.

África do Sul - inglês - South African Health Products Regulatory Authority (SAHPRA)

cipla medpro manufacturing (pty) ltd - pellet - see ingredients - each capsule contains lopinavir 40,0 mg ritonavir 10,0 mg

África do Sul - inglês - South African Health Products Regulatory Authority (SAHPRA)

cipla medpro manufacturing (pty) ltd - pellet - see ingredients - each capsule contains lopinavir 40,0 mg ritonavir 10,0 mg

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

viatris limited - buspirone hydrochloride 10mg;   - tablet - 10 mg - active: buspirone hydrochloride 10mg   excipient: colloidal anhydrous silica lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression. the diagnosis of patients studied in controlled clinical trials of buspirone corresponds to the generalised anxiety disorder of the who classification as described below: generalised, persistent anxiety is manifested by symptoms from three of the following four categories: general tensions: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. autonomic hyperactivity: sweating, heart pounding or racing, cold clammy hands, dry mouth, dizziness, lightheadedness, paraesthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhoea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. apprehensive expectations: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. vigilance and scanning: hypertensiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling ?on edge?, irritability, impatience. the anxious mood has been continuous for at least one month. the ordinary anxiety and tension associated with the stress of everyday life usually does not require treatment with an anxiolytic agent. controlled clinical studies of buspirone have been limited to six months.

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

viatris limited - buspirone hydrochloride 5mg;   - tablet - 5 mg - active: buspirone hydrochloride 5mg   excipient: colloidal anhydrous silica lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression. the diagnosis of patients studied in controlled clinical trials of buspirone corresponds to the generalised anxiety disorder of the who classification as described below: generalised, persistent anxiety is manifested by symptoms from three of the following four categories: general tensions: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. autonomic hyperactivity: sweating, heart pounding or racing, cold clammy hands, dry mouth, dizziness, lightheadedness, paraesthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhoea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. apprehensive expectations: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. vigilance and scanning: hypertensiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling ?on edge?, irritability, impatience. the anxious mood has been continuous for at least one month. the ordinary anxiety and tension associated with the stress of everyday life usually does not require treatment with an anxiolytic agent. controlled clinical studies of buspirone have been limited to six months.

Israel - inglês - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 75 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

Israel - inglês - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 150 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

União Europeia - inglês - EMA (European Medicines Agency)

meda ab - zaleplon - sleep initiation and maintenance disorders - psycholeptics - sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. it is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

União Europeia - inglês - EMA (European Medicines Agency)

meda ab - zaleplon - sleep initiation and maintenance disorders - psycholeptics - zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. it is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)