Slenyto European Union - English - EMA (European Medicines Agency)

slenyto

rad neurim pharmaceuticals eec sarl - melatonin - sleep initiation and maintenance disorders; autistic disorder - psycholeptics - slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (asd) and / or smith-magenis syndrome, where sleep hygiene measures have been insufficient.

AC PULVERIZE 75-D HERBICIDE Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ac pulverize 75-d herbicide

axichem pty ltd - picloram as the triisopropanolamine salt; 2,4-d as the triisopropanolamine salt - soluble concentrate - picloram as the triisopropanolamine salt anilide/aniline-pyrimidine active 75.0 g/l; 2,4-d as the triisopropanolamine salt phenoxy acids-2,4-d-amine active 300.0 g/l - herbicide - barley | canary grass | commercial/industrial land | fallow or stubble,prior to winter cereal | maize | oats | pasture | rights - african boxthorn | alkaki or ivyleaf sida | amaranth or amaranthus | amsinckia | apple-of-sodom | artichoke thistle | bathurst burr | bellvine | bindweed | bitou bush or boneseed | black bindweed | black knapweed | blackberry | bladder campion | bladder ketmia | blue heliotrope or blue top | borreria | boxthorn | broadleaf weeds | brooms | burr ragweed | californian thistle | caltrop or yellow vine | camelthorn | cape honey flower | cape or montpellier broom | chilean cestrum | chinese scrub | climbing buckwheat | cobbler's pegs | colocynth | common heliotrope | creeping/russian knapweed,hardhead | crofton weed | cutleaf mignonette | datura spp. | devil's-fig | dock | dog rose | english broom | eucalyptus | fat hen | furze or gorse | giant or black pigweed | golden thistle | gooseberry | groundsel bush | hawthorn | hoary cress or whiteweed | inkweed | khaki weed | lantana spp. | limebush | lucerne | mayne's pest | melilotus or hexham scent | mexican poppy | mintweed | mistflower or creeping crofton weed | mor

ADALICIP adalimumab 80 mg/0.8 mL solution for subcutaneous injection pre-filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

adalicip adalimumab 80 mg/0.8 ml solution for subcutaneous injection pre-filled syringe

cipla australia pty ltd - adalimumab, quantity: 80 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

ADALICIP adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled pen Australia - English - Department of Health (Therapeutic Goods Administration)

adalicip adalimumab 40 mg/0.4 ml solution for subcutaneous injection pre-filled pen

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

ADALICIP adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

adalicip adalimumab 40 mg/0.4 ml solution for subcutaneous injection pre-filled syringe

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

ac terbulence herbicide

axichem pty ltd - mcpa present as the potassium salt; terbutryn - suspension concentrate - mcpa present as the potassium salt phenoxy acids-mcpa active 160.0 g/l; terbutryn triazine active 275.0 g/l - herbicide - barley | oats - see label for varieties | subclover pasture - see lbl 4 varieties | sugar cane | wheat | bacchus marsh | clare | - australian crassula | ball mustard - suppression | barnyard or water grass | bellvine | blackberry nightshade | blue billygoat weed | blue billygoat weed - suppression | calopo | capeweed | capeweed - seedling | centro | charlock | cinderella weed | common morning glory | common sensitive plant | corn gromwell, ironweed or sheepweed | crassula | crowsfoot grass | deadnettle | fat hen | fumitory - red | fumitory - white | giant or black pigweed | giant sensitive plant | green summer grass | ground or annual ground cherry | guinea grass | indian hedge mustard | ivy leaf speedwell | long storksbill - seedling | mallee catchfly | melilotus or hexham scent | native jute | paterson's curse | paterson's curse - seedling | perennial pigweed | pimpernels | pink convolvulus | pinkburr | rattlepod | red convolvulus | rough poppy | rounded chamomile | saffron thistle | scented woolly sage | sow or milk thistle | square weed or borreria | star of bethlehem or cupid's flower | stemless thistle | stinking passion flower or

AC MUT 700 HERBICIDE Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ac mut 700 herbicide

axichem pty ltd - glyphosate present as the mono-ammonium salt - water soluble granules - glyphosate present as the mono-ammonium salt glycine active 700.0 g/kg - herbicide - agricultural/farm buildings | almond | annual grass weed - seed set control | avocado | banana | blueberry | buildings - around - african lovegrass | african turnip weed | amaranth or amaranthus | amsinckia | annual phalaris | annual ryegrass | annual weeds | artichoke thistle | australian bluebell - w. gracilis | bamboo | barley grass | barnyard or water grass | bathurst burr | bent grass - agrostis spp. | bitou bush or boneseed | blackberry | bladder ketmia | blady grass | boggabri weed | boxthorn | bracken | brome grass | burr medic | calomba daisy | caltrop or yellow vine | camel or afghan melon | canary grass | capeweed | carpet grass | cat's ear or flatweed | chickweed | chinese scrub | cobbler's pegs | cocksfoot | columbus grass - seedling | couch | cudweed | cumbungi | deadnettle | dock | dock - seedling | english couch or rope twitch | erodium, crowfoot or storksbill | eucalyptus - seedling up to 2 m tall | fumitory | furze or gorse | giant or black pigweed | glyceria or reed sweet grass | gooseberry | ground cherry - physalis angulata | groundsel bush | guinea grass | hawthorn | hedge or wild mustard | hoary cress or whiteweed