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

amgen australia pty ltd - adalimumab, quantity: 20 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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 who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita 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 amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita 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 of infliximab.,ulcerative colitis amgevita 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.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita 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.

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

amgen australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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 who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita 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 amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) amgevita 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 of infliximab.,ulcerative colitis amgevita 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.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita 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.

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

amgen australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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 who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita 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 amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita 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 of infliximab.,ulcerative colitis amgevita 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.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita 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.

Israel - English - Ministry of Health

amgen europe b.v. - adalimumab - solution for injection - adalimumab 50 mg / 1 ml - adalimumab - rheumatoid arthritisamgevita in combination with methotrexate is indicated for:• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.axial spondyloarthritisankylosing spondylitis (as):amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.axial spondyloarthritis without radiographic evidence of as:amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels, who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs.psoriatic arthritisamgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease to improve physical function.psoriasisamgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.hidradenitis suppurativa (hs)amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.crohn’s diseaseamgevita is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. amgevita is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.ulcerative colitisamgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.uveitisamgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.intestinal behcet's diseaseamgevita is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritis  amgevita in combination with methotrexate, is indicated for: , the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate., the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.  amgevita reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years. enthesitis-related arthritis amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). axial spondyloarthritis ankylosing spondylitis (as) amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. psoriatic arthritis amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. amgevita reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs) amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5.1 and 5.2). crohn’s disease amgevita is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's disease amgevita is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitis amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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. paediatric uveitis amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.,

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

amgrow pty ltd - bifenthrin - emulsion - oil in water - bifenthrin pyrethroid active 0.5 g/l - insecticide - building foundations - around | domestic area - outdoors | domestic pest control | domestic premises | guttering | air vents | a - ant | cockroach | flea | fly | mosquito | paper nest wasp | spider | adult mosquitoes | argentine ant | large cockroach | papernest wasps | pharaoh ant | small cockroach

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

amgrow pty ltd - petroleum oil - emulsion - oil in water - petroleum oil petroleum derivative-oil active 20.0 g/l - insecticide - citrus fruit (see label for exceptions) | grape | ornamental (see label) | pome fruit tree - established | rose | stone fruit or - aphid | black scale | citrus leafminer | grapevine scale | mealy bug | oystershell scale | pink scale | red scale | san jose' scale | scale | soft brown scale | spider mite | white wax scale | whitefly | citrus red scale | diaspidiotus ostreaeformis | diaspidiotus perniciosus | mealybug | quadraspidiotus perniciosus

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

amgrow pty ltd - tau-fluvalinate; myclobutanil - suspension concentrate - tau-fluvalinate pyrethroid active 9.6 g/l; myclobutanil triazole active 4.4 g/l - mixed function pesticide - ornamental | rose | carnation | chrysanthemum | indoor foliage plant | rose | sturt's desert rose - aphid | black spot | helicoverpa spp. | native budworm or bollworm | powdery mildew | rust | thrip | two spotted mite | whitefly | corn earworm | cotton bollworm | heliothis | native bollworm | native budworm | red spider mite | scab | spider mite | thrips spp. | tobacco budworm | tomato grub | two-spotted mite | two-spotted spider mite

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

amgrow pty ltd - permethrin - dust - permethrin pyrethroid active 20.0 g/kg - household insecticide - house - general | apartment | flat - residential | household area | residential structure - ant | cockroach | flea | silverfish | spider | argentine ant | ctenocephalides spp. | ground fleas | large cockroach | pharaoh ant | small cockroach

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

amgrow pty ltd - bifenthrin - granular formulation - bifenthrin pyrethroid active 2.0 g/kg - insecticide - lawn - african black beetle | argentine stem weevil | bill bug | lawn armyworm | sod webworm | weevil | billbug | grass caterpillar | grass grub | la plata weevil | lawn caterpillar