Israel - English - Ministry of Health

medison pharma ltd - peginterferon beta 1a - solution for injection - peginterferon beta 1a 94 mcg / 0.5 ml - peginterferon beta-1a - plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis

Israel - English - Ministry of Health

bayer israel ltd - interferon beta 1b - powder and solvent for solution for injection - interferon beta 1b 0.3 mg/vial - interferon beta-1b - interferon beta-1b - use in ambulatory patients with relapsing-remitting multiple sclerosis (rrms) and relapsing progressive m.s. to reduce the frequency of clinical exacerbations. treatment of secondary progressive (sp) form of multiple sclerosis. treatment of patients who have experienced 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, including the prescence of mri abnormalities characteristic of m.s. and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

European Union - English - 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.

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

novartis pharmaceuticals corporation - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1.0 ml - extavia is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. extavia is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. risk summary although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of interferon beta-1b to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respective

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - interferon beta-1b 0.25mg (20% excess in quantity filled) - injection with diluent - 8 miu - active: interferon beta-1b 0.25mg (20% excess in quantity filled) excipient: albumin hydrochloric acid mannitol sodium hydroxide hydrochloric acid sodium chloride water for injection - betaferon is indicated for: · the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, · the treatment of ambulatory patients, with relapsing-remitting multiple sclerosis characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

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

bayer australia ltd - interferon beta-1b, quantity: 0.25 mg/ml - injection, powder for - excipient ingredients: albumin; mannitol - betaferon is indicated for the treatment of: - ambulatory patients with relapsing-remitting multiple sclerosis (ms) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

New Zealand - English - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - peginterferon beta-1a 94ug;  ; peginterferon beta-1a 63ug - solution for injection - active: peginterferon beta-1a 94ug   excipient: arginine hydrochloride glacial acetic acid polysorbate 20 sodium acetate trihydrate water for injection active: peginterferon beta-1a 63ug excipient: arginine hydrochloride glacial acetic acid polysorbate 20 sodium acetate trihydrate water for injection - plegridy is indicated for the treatment of relapsing forms of multiple sclerosis

New Zealand - English - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - peginterferon beta-1a 125ug;   - solution for injection - 125 mcg/0.5ml - active: peginterferon beta-1a 125ug   excipient: arginine hydrochloride glacial acetic acid polysorbate 20 sodium acetate trihydrate water for injection - plegridy is indicated for the treatment of relapsing forms of multiple sclerosis

European Union - English - EMA (European Medicines Agency)

biogen netherlands b.v. - peginterferon beta-1a - multiple sclerosis - immunostimulants, - treatment of relapsing remitting multiple sclerosis in adult patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - interferon beta-1a 30ug;   - injection with diluent - 30 mcg - active: interferon beta-1a 30ug   excipient: albumin dibasic sodium phosphate monobasic sodium phosphate sodium chloride water for injection - indicated for the treatment of relapsing forms of multiple sclerosis (ms).