J05AB04 - search results

ribavirin 200mg capsules

milpharm limited - ribavirin - capsule, hard - 200mg - direct acting antivirals, nucleosides and nucleotides (excl.reverse transcriptase inhibitors) - adult patients: ribavirin is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for hepatitis c viral ribonucleic acid hcv-rna children 3 years of age and older and adolescents: ribavirin is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis c, except genotype 1, not previously treated, without liver decompensation, and who are positive for hcv-rna. when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis

European Union - English - EMA (European Medicines Agency)

ribavirin mylan (previously ribavirin three rivers)

mylan s.a.s - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin mylan is indicated for the treatment of chronic hepatitis c and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). ribavirin monotherapy must not be used.there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).please refer also to the interferon alfa-2b summary of product characteristics (smpc) for prescribing information particular to that product.naïve patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for serum hepatitis-c-virus (hcv) rna.children and adolescentsribavirin mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for serum hcv rna. when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case-by-case basis (see section 4.4).previously treatment-failure patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

European Union - English - EMA (European Medicines Agency)

ribavirin biopartners

biopartners gmbh - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin biopartners is indicated for the treatment of chronic hepatitis-c-virus (hcv) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. ribavirin monotherapy must not be used. there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).naïve patientsadult patientsribavirin biopartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for hepatitis c viral ribonucleic acid (hcv-rna) (see section 4.4)children three years of age and older and adolescentsribavirin biopartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for hcv-rna.when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).previous-treatment-failure patientsadult patientsribavirin biopartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).

Israel - English - Ministry of Health

rebetol

merck sharp & dohme israel ltd - ribavirin - capsules - ribavirin 200 mg - ribavirin - ribavirin - tritherapy:rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis c (chc) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.bitherapy:rebetol is indicated for the treatment of chronic hepatitis c virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b .rebetol monotherapy must not be used. there is no safety or efficacy information on the use of rebetol with other forms of interferon (i.e., not alfa-2b).previously untreated (naïve) patientsadult patients (18 years of age or older): rebetol is indicated for:• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis c genotype1 infection with compensated liver disease.• bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, fo

Israel - English - Ministry of Health

copegus

roche pharmaceuticals (israel) ltd - ribavirin 200 mg - tablets - ribavirin - copegus in combination with peginterferon alfa 2a or interferon alfa - 2a is indicated in adult patients who are positive for serum hcv-rna, including patients with compensated cirrhosis . the combination with peginterferon alfa-2a is also indicated in patients co-infected with clinically stable hiv , including patients with compensated cirrhosis . copegus, in combination with peginterferon alfa-2a, is indicated in naive patients and patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.