United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 270microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 360microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 270microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 360microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 180microgram/1ml

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - peginterferon alfa 2a 135 mcg / 0.5 ml - solution for injection - peginterferon alfa-2a - chronic hepatitis b: pegasys is indicated for the treatment of both hbeag- positive and hbeag -negative chronic hepatitis b in non-cirrhotic and cirrhotic adult patients with compensated liver disease and evidence of viral replication and liver inflammation.chronic hepatitis c: pegasys is indicated for the treatment of chronic hepatitis c in adult patients who are positive for serum hcv-rna including patients with compensated cirrhosis and/or co-infected with clinically stable hiv. the optimal way to use pegasys in patients with chronic hepatitis c is in combination with ribavirin. the combination of pegasys and ribavirin 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. monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - peginterferon alfa 2a 180 mcg / 0.5 ml - solution for injection - peginterferon alfa-2a - chronic hepatitis b: pegasys is indicated for the treatment of both hbeag- positive and hbeag -negative chronic hepatitis b in non-cirrhotic and cirrhotic adult patients with compensated liver disease and evidence of viral replication and liver inflammation.chronic hepatitis c: pegasys is indicated for the treatment of chronic hepatitis c in adult patients who are positive for serum hcv-rna including patients with compensated cirrhosis and/or co-infected with clinically stable hiv. the optimal way to use pegasys in patients with chronic hepatitis c is in combination with ribavirin. the combination of pegasys and ribavirin 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. monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.

Singapore - English - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - peginterferon alfa-2a - injection - 135 mcg/0.5 ml - peginterferon alfa-2a 135 mcg/0.5 ml

Singapore - English - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - peginterferon alfa-2a - injection - 180 mcg/0.5 ml - peginterferon alfa-2a 180 mcg/0.5 ml

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1). paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. with respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). for hepatitis c virus (hcv) genotype specific activity, see sections 4.2 and 5.1. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. when deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).,