Israël - Engels - Ministry of Health

abbvie biopharmaceuticals ltd, israel - adalimumab - solution for injection - adalimumab 100 mg / 1 ml - adalimumab - • rheumatoid arthritis:humira 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.humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.humira 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.• polyarticular juvenile idiopathic arthritis:humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. humira has not been studied in patients aged less than 2 years.• enthesitis-related arthritis:humira 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.• axial spondyloarthritis :humira 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:humira 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 arthritis:humira 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. humira 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 and to improve physical function.• psoriasis:humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• paediatric plaque psoriasis:humira 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):humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy.• crohn’s disease:humira 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. humira 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. • paediatric crohn's disease:humira 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 corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies• ulcerative colitis:humira 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:humira 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.• intestinal behcet's disease:humira is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.• paediatric uveitishumira is indicated for the treatment of chronic non-infectious uveitis in paediatric 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.• paediatric ulcerative colitis humira is indicated for the treatment of moderately to severely active ulcerative colitis in pediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies

Maleisië - Engels - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abbvie sdn bhd - risankizumab -

Israël - Engels - Ministry of Health

abbvie biopharmaceuticals ltd, israel - lopinavir; ritonavir - solution (oral) - ritonavir 20 mg/ml; lopinavir 80 mg/ml - ritonavir - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Israël - Engels - Ministry of Health

abbvie biopharmaceuticals ltd, israel - lopinavir; ritonavir - solution (oral) - ritonavir 20 mg/ml; lopinavir 80 mg/ml - ritonavir - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - 37685 - bag, medical device, reusable - the abbvie carrying accessories are designed to carry a cadd-legacy? 1400 pump. the abbvie carrying accessories are intended for single patient use only.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

abbvie limited - ritonavir 100mg - film coated tablet - 100 mg - active: ritonavir 100mg excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry white 16b18449 sodium stearyl fumarate sorbitan laurate - norvir is indicated for use in combination with appropriate antiretroviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of hiv-1 infection in adults and children aged 12 years and older. for persons with advanced hiv disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and aids defining clinical events for patients who received ritonavir. median duration of follow-up in this study was 6 months. the clinical benefit from ritonavir for longer periods of treatment is unknown. for persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks duration.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

abbvie limited - venetoclax 10mg;  ; venetoclax 50mg; venetoclax 100mg - film coated tablet - active: venetoclax 10mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate active: venetoclax 50mg excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii beige 85f97497 polysorbate 80 purified water sodium stearyl fumarate active: venetoclax 100mg excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate - venclexta is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

abbvie limited - venetoclax 10mg;   - film coated tablet - 10 mg - active: venetoclax 10mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate - venclexta is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

abbvie limited - venetoclax 100mg;   - film coated tablet - 100 mg - active: venetoclax 100mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate - venclexta is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

abbvie limited - venetoclax 50mg;   - film coated tablet - 50 mg - active: venetoclax 50mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii beige 85f97497 polysorbate 80 purified water sodium stearyl fumarate - venclexta is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).