European Union - English - EMA (European Medicines Agency)

amgen europe bv - apremilast - arthritis, psoriatic; psoriasis - immunosuppressants - psoriatic arthritisotezla, alone or in combination with disease modifying antirheumatic drugs (dmards), is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior dmard therapy.psoriasisotezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-a light (puva).

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - solution for injection - ustekinumab 45 mg / 0.5 ml - ustekinumab - ustekinumab - *plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus u.v (puva) paediatric plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, othersystemic therapies or phototherapies.psoriatic arthritis (psa)stelara, alone or in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (dmard) therapy has been inadequatecrohn’s diseasestelara is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnfα antagonist or have medical contraindications to such therapies.ulcerative colitisstelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - solution for injection - ustekinumab 45 mg / 0.5 ml - ustekinumab - ustekinumab - plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus u.v (puva) paediatric plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, othersystemic therapies or phototherapies.psoriatic arthritis (psa)stelara, alone or in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (dmard) therapy has been inadequatecrohn’s diseasestelara is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnfα antagonist or have medical contraindications to such therapies.ulcerative colitisstelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - solution for injection - ustekinumab 45 mg / 0.5 ml - ustekinumab - * pque poriasis stelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, or have contraindication to or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus u.v (puva).* psoriatic arthritisstelara, alone or in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (dmard) therapy has been inadequatepediatric plaque psoriasis:stelara is indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* crohn’s disease:stelara is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnfα antagonist or have medical contraindications to such therapies.

United States - English - NLM (National Library of Medicine)

strides pharma science limited - methoxsalen (unii: u4vj29l7bq) (methoxsalen - unii:u4vj29l7bq) - methoxsalen 10 mg - photochemotherapy (methoxsalen with long wave uva radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation. a.    patients exhibiting idiosyncratic reactions to psoralen compounds. b.     patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances. diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. c.     patients with melanoma or with a history of melanoma. d.    patients with invasive squamous cell carcinomas. e.     patients with aphakia, because of the significantly increased risk of retinal damage due to the abse

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - infliximab - solution for injection - infliximab 120 mg/ml - infliximab - rheumatoid arthritis: remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:•adult patients with active disease when the response to disease-modifying antirheumatic drugs (dmards),including methotrexate, has been inadequate. •adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards. in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x ray,has been demonstrated.crohn’s diseaseremsima 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.• treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).ulcerative colitisremsima 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.ankylosing spondylitisremsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisremsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.remsima should be administered• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease.psoriasisremsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet a (puva).

European Union - English - EMA (European Medicines Agency)

therakind (europe) limited - methotrexate - arthritis, psoriatic; precursor cell lymphoblastic leukemia-lymphoma; psoriasis; arthritis, rheumatoid; arthritis - antineoplastic agents - in rheumatological and dermatological diseasesactive rheumatoid arthritis in adult patients.polyarthritic forms of active, severe juvenile idiopathic arthritis (jia) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequate.severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet a radiation (puva) therapy and retinoids, and severe psoriatic arthritis in adult patients.in oncologymaintenance treatment of acute lymphoblastic leukaemia (all) in adults, adolescents and children aged 3 years and over.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - infliximab - powder for concentrate for solution for infusion - infliximab 100 mg - infliximab - rheumatoid arthritis:ixifi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:• adult patients with active disease when the response to disease modifying antirheumatic drugs (dmards),including methotrexate, has been inadequate.• adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards.in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x ray, has been demonstrated.* ankylosing spondylitis:ixifi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* psoriatic arthritis:ixifi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.* ixifi should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x ray in patients with polyarticular symmetrical subtypes of the disease.* psoriasis:ixifi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet a (puva)* adult crohn’s diseaseixifi 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.• treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).* ulcerative colitis• ixifi 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.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - infliximab - powder for concentrate for solution for infusion - infliximab 100 mg/vial - infliximab - * rheumatoid arthritis:remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:• adult patients with active disease when the response to disease modifying antirheumatic drugs (dmards),including methotrexate, has been inadequate.• adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards.in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x ray,has been demonstrated.* ankylosing spondylitis:remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* psoriatic arthritis:remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.* remsima should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x ray in patients with polyarticular symmetrical subtypes of the disease.* psoriasis:remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet a (puva)* adult crohn’s disease remsima 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.• treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).* ulcerative colitis• remsima 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.paediatric crohn’s diseaseremsima is indicated for treatment of severe, active crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. infliximab has been studied only in combination with conventional immunosuppressive therapy.paediatric ulcerative colitisremsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 mp or aza, or who are intolerant to or have medical contraindications for such therapies.

India - English - Central Drugs Standard Control Organization

wyeth - psoralen - oint - 10mg/g - 30g