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

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 160 mg; hydrochlorothiazide, quantity: 12.5 mg; amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 4000 - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - vaccines - active immunisation against h5n1 subtype of influenza a virus.; this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

Philippines - English - FDA (Food And Drug Administration)

novartis pharma ag; importer: novartis healthcare philippines, inc.; distributor: novartis healthcare philippines, inc. - ofatumumab - solution for injection (sc) - 20 mg/ 0.4 ml

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - lumiracoxib 100mg (release testing to occur at novartis ag, lichstrasse, basel.) - film coated tablet - 100 mg - active: lumiracoxib 100mg (release testing to occur at novartis ag, lichstrasse, basel.) excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry   opadry white 00f18296 povidone titanium dioxide

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - lumiracoxib 200mg (release testing to occur at novartis ag, lichstrasse, basel.) - film coated tablet - 200 mg - active: lumiracoxib 200mg (release testing to occur at novartis ag, lichstrasse, basel.) excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry black 00f17713 opadry red 00f15613 opadry white 00f18296 povidone titanium dioxide

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - lumiracoxib 400mg (release testing to occur at novartis ag, lichstrasse, basel.) - film coated tablet - 400 mg - active: lumiracoxib 400mg (release testing to occur at novartis ag, lichstrasse, basel.) excipient: croscarmellose sodium 00f17713 basic coating premix black magnesium stearate microcrystalline cellulose opadry opadry white 00f18296 povidone

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

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - influenza virus surface antigens (haemagglutinin and neuraminidase) a/vietnam/1194/2004 (h5n1) - like strain used (nibrg-14) - injection, suspension - >or= 7.5 ug ha

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

novartis pharmaceuticals australia pty ltd - octreotide -