Israel - English - Ministry of Health

novartis israel ltd - secukinumab - solution for injection - secukinumab 150 mg/ml - secukinumab - - plaque psoriasis: cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. - paediatric plaque psoriasis: cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. - psoriatic arthritis: cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (dmard) therapy has been inadequate. - axial spondyloarthritis (axspa) : •ankylosing spondylitis (as, radiographic axial spondyloarthritis) cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. •non-radiographic axial spondyloarthritis (nr-axspa) cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (nsaids). - juvenile idiopathic arthritis (jia) •enthesitis-related arthritis (era) cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitisrelated arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. •juvenile psoriatic arthritis (jpsa) cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy

Israel - English - Ministry of Health

novartis israel ltd - canakinumab - powder for solution for injection - canakinumab 150 mg / 1 ml - canakinumab - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is i

Egypt - English - EDA (Egyptian Drug Authority)

novartis pharma egypt - injection - 1 mg/ml

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - mycophenolate sodium 192.4mg eqv mycophenolic acid - enteric coated tablet - 192.4mg - mycophenolate sodium 192.4mg eqv mycophenolic acid 180mg

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - mycophenolate sodium 384.8mg eqv mycophenolic acid - tablet, film coated - 384.8 mg - mycophenolate sodium 384.8mg eqv mycophenolic acid 360 mg

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - canakinumab - powder, for solution - 150mg - canakinumab 150mg

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

novartis pharmaceuticals australia pty ltd - mycophenolate sodium -

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - methylphenidate hydrochloride - tablets - 10 milligram - centrally acting sympathomimetics

Israel - English - Ministry of Health

novartis israel ltd - canakinumab - solution for injection - canakinumab 150 mg / 1 ml - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is indicated for the treatment of hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd).►familial mediterranean fever (fmf)ilaris is indicated for the treatment of familial mediterranean fever (fmf) in patients in whom colchicine is contraindicated, is not tolerated, or does not provide an adequate response despite the highest tolerable dose of colchicine.ilaris can be given as monotherapy or in combination with colchicine.ilaris is also indicated for the treatment of:►still’s diseaseilaris is indicated for the treatment of active still’s disease including adult-onset still’s disease (aosd) and systemic juvenile idiopathic arthritis (sjia) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (nsaids) and systemic corticosteroids. ilaris can be given as monotherapy or in combination with methotrexate.►gouty arthritisilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (nsaids) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - secukinumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: secukinumab 150 mg/ml   excipient: histidine hydrochloride monohydrate methionine nitrogen polysorbate 80 trehalose dihydrate water for injection - cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.