Ireland - English - HPRA (Health Products Regulatory Authority)

roche products limited - interferon alfa-2a - solution for injection - 9miu/0.5ml %v/v - interferons

European Union - English - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

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

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

bayer healthcare pharmaceuticals inc. - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1 ml - betaseron 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. betaseron is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of betaseron 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 2-4% and 15-20%, respectively. the background risk o

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

genentech, inc. - peginterferon alfa-2a (unii: q46947fe7k) (peginterferon alfa-2a - unii:q46947fe7k) - peginterferon alfa-2a 180 ug in 1 ml - adult patients: pegasys, as part of a combination regimen with other hepatitis c virus (hcv) antiviral drugs, is indicated for the treatment of adults with chc and compensated liver disease. for information about the safe and effective use of other hcv antiviral drugs to be used in combination with pegasys, refer to their prescribing information. pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. pediatric patients: pegasys in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with chc and compensated liver disease. limitations of use : - pegasys alone or in combination with ribavirin without additional hcv antiviral drugs is not recommended for treatment of patients with chc who previously failed therapy with an interferon-alfa. - pegasys is not recommended for treatment of patients with chc who have had solid

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

biogen inc. - peginterferon beta-1a (unii: i8309403r0) (peginterferon beta-1a - unii:i8309403r0) - peginterferon beta-1a 94 ug in 0.5 ml - plegridy 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. plegridy is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of plegridy [see warnings and precautions ( 5.3)] . risk summary data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see data). in a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion (see data ). in the u.s. general population, the estimated backgro

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

biogen inc. - interferon beta-1a (unii: xro4566q4r) (interferon beta-1a - unii:xro4566q4r) - interferon beta-1a 30 ug in 0.5 ml - avonex 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. avonex is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see warnings and precautions (5.3)] . the formerly available lyophilized vial formulation of avonex is contraindicated in patients with a history of hypersensitivity to albumin (human). risk summary data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see data). in a study in pregnant monkeys, administration of interfer

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

roche sa-nv - interferon alfa-2a 6000000 iu/ml - solution for injection in pre-filled syringe - 3 miu - interferon alfa-2a 3000000 iu - interferon alfa-2a

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

roche sa-nv - interferon alfa-2a 12000000 iu/ml - solution for injection in pre-filled syringe - 6 miu - interferon alfa-2a 6000000 iu - interferon alfa-2a

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

roche sa-nv - interferon alfa-2a 18000000 iu/ml - solution for injection in pre-filled syringe - 9 miu - interferon alfa-2a 9000000 iu - interferon alfa-2a