Evropska unija - angleščina - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; psoriasis; arthritis, psoriatic; spondylitis, ankylosing; uveitis; colitis, ulcerative; crohn disease - immunosuppressants - rheumatoid arthritiskromeya 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.kromeya 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.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritiskromeya 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). idacio 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 arthritiskromeya 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 spondyloarthritisankylosing spondylitis (as)kromeya 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 askromeya 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 nonsteroidal anti-inflammatory drugs.psoriatic arthritiskromeya 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 (see section 5.1) and to improve physical function.psoriasiskromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasiskromeya 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.crohn’s diseasekromeya 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 diseasekromeya 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 colitiskromeya 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.uveitiskromeya 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 uveitiskromeya 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.

Evropska unija - angleščina - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosuppressants - please refer to section 4.1 of the summary of product characteristics in the product information document.,

Malta - angleščina - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Malta - angleščina - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 40 mg - drugs for acid related disorders

Malta - angleščina - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Malta - angleščina - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 40 mg - drugs for acid related disorders

Malta - angleščina - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Malta - angleščina - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - gastro-resistant tablet - pantoprazole 40 mg - drugs for acid related disorders

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 47986 - female stress urinary incontinence surgical mesh - procedural kit:tvt abbrevo implant assembly(mesh implant & sheath,polyethylene tube receptacles/helical passers,placement loop with attached polypropylene button,positioning lines & atraumatic winged guide. curved hps preassembled to implant assembly to deliver mesh implant via trans-obturator insideout approach.atraumatic winged guide facilitates passage of hps thru dissection tract, marked with insertion zone-aids surgeon?s assessment of inserted depth. iz indicates distance 3-4cm from tip wg. gynecare tvt? abbrevo? continence system is intended for use in women as a sub-urethral sling for the treatment of sui resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Irska - angleščina - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - quetiapine fumarate - film-coated tablet - 300 milligram(s) - diazepines, oxazepines, thiazepines and oxepines; quetiapine