Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: mannitol; iron oxide yellow; magnesium stearate; gelatin; titanium dioxide - gilenya is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: gelatin; fumaric acid; stearic acid; pregelatinised maize starch; titanium dioxide; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolis is indicated for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

Európska únia - angličtina - EMA (European Medicines Agency)

sanofi belgium - alemtuzumab - multiple sclerosis - selective immunosuppressants - lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (rrms) with active disease defined by clinical or imaging features.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, modified release - excipient ingredients: ethanol; iron oxide black; purified water; iron oxide yellow; gelatin; propylene glycol; triethyl citrate; purified talc; strong ammonia solution; butan-1-ol; shellac; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; methacrylic acid copolymer; isopropyl alcohol; glyceryl monostearate 40-55 per cent; colloidal anhydrous silica; brilliant blue fcf; sodium stearylfumarate; polysorbate 80; titanium dioxide - dimethyl fumarate sandoz is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, modified release - excipient ingredients: colloidal anhydrous silica; glyceryl monostearate 40-55 per cent; gelatin; shellac; isopropyl alcohol; purified talc; propylene glycol; triethyl citrate; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; butan-1-ol; methacrylic acid copolymer; iron oxide black; ethanol; sodium stearylfumarate; purified water; iron oxide yellow; brilliant blue fcf; polysorbate 80; strong ammonia solution - dimethyl fumarate sandoz is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Európska únia - angličtina - EMA (European Medicines Agency)

bayer ag  - interferon beta-1b - multiple sclerosis - immunostimulants, - betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Európska únia - angličtina - EMA (European Medicines Agency)

novartis europharm limited - interferon beta-1b - multiple sclerosis - immunostimulants, - extavia is indicated for the treatment of:patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Európska únia - angličtina - EMA (European Medicines Agency)

novartis europharm limited - fingolimod hydrochloride  - multiple sclerosis - immunosuppressants - gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1).orpatients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.