European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - entecavir - hepatitis b, chronic - antivirals for systemic use - baraclude is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b.

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

ausmedic australia pty ltd - 58060 - virtual-display arm rehabilitation system, non-gravity-compensating - an assembly of devices designed to provide non-gravity-compensating therapy for a patient who has lost motor function of the arm(s) caused by cerebral, neurogenic, spinal, muscular or bone-related disorders through interaction with a computer program prompting repeated motion of the arms, fingers, and hands to improve grip strength, range of motion, and train fine and gross motor tasks that mimic activities of daily living. it consists of a joystick, visual display unit (vdu), and computer-calculated arm/finger position and training program. it is used for inpatients, outpatients or home settings for patients able to understand and interact with the audio-visual instructions..

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

interpharma pty ltd - esmolol hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium acetate trihydrate; glacial acetic acid; hydrochloric acid; water for injections; sodium hydroxide; sodium chloride - supraventricular tachycardia - esmolol noridem is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol noridem is also indicated in non-compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. esmolol noridem is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

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

medsurge pharma pty ltd - esmolol hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - esmolol hydrochloride medsurge is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol hydrochloride medsurge is also indicated in non-compensatory sinus tachycardia where, in the physician?s judgement, the rapid heart rate requires specific intervention. esmolol hydrochloride medsurge is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

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

arrotex pharmaceuticals pty ltd - adefovir dipivoxil, quantity: 10 mg - tablet - excipient ingredients: pregelatinised maize starch; magnesium stearate; purified talc; croscarmellose sodium; lactose monohydrate - ? adefovir dipivoxil is indicated for the treatment of chronic hepatitis b in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. ? for adult patients, this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag-/hbvdna+ chronic hepatitis b with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. ? for adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus with compensated liver function.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - hepatitis b, chronic - antivirals for systemic use - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease. , for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b. entecavir accord is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir monohydrate - hepatitis b - antivirals for systemic use - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b.entecavir mylan is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

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

phebra pty ltd - esmolol hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium acetate trihydrate; glacial acetic acid - supraventricular tachycardia - for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol is also indicated in non-compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. esmolol is not intended for use in chronic settings where transfer to another agent is anticipated, or for treatment periods greater than 24 hours duration.

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

phebra pty ltd - esmolol hydrochloride, quantity: 250 mg/ml - injection, concentrated - excipient ingredients: propylene glycol; ethanol; water for injections; hydrochloric acid; sodium hydroxide; sodium acetate; glacial acetic acid - supraventricular tachycardia - for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol is also indicated in non-compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. esmolol is not intended for use in chronic settings where transfer to another agent is anticipated, or for treatment periods greater than 24 hours duration.

Israel - English - Ministry of Health

teva israel ltd - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 0.5 mg - entecavir - entecavir teva is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated liver disease.