New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - peginterferon alfa-2b 120ug - injection with diluent - 120 mcg - active: peginterferon alfa-2b 120ug excipient: dibasic sodium phosphate monobasic sodium phosphate dihydrate polysorbate 80 sucrose water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - peginterferon alfa-2b 150ug - injection with diluent - 150 mcg - active: peginterferon alfa-2b 150ug excipient: dibasic sodium phosphate monobasic sodium phosphate dihydrate polysorbate 80 sucrose water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - peginterferon alfa-2b 50ug - injection with diluent - 50 mcg - active: peginterferon alfa-2b 50ug excipient: dibasic sodium phosphate monobasic sodium phosphate dihydrate polysorbate 80 sucrose water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - peginterferon alfa-2b 80ug - injection with diluent - 80 mcg - active: peginterferon alfa-2b 80ug excipient: dibasic sodium phosphate monobasic sodium phosphate dihydrate polysorbate 80 sucrose water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - peginterferon alfa-2a 270 µg/ml - solution for injection - 135 mcg/0.5ml - active: peginterferon alfa-2a 270 µg/ml excipient: acetic acid benzyl alcohol glacial acetic acid sodium acetate soln 10% polysorbate 80 sodium acetate trihydrate sodium chloride water for injection - latest regulatory activity

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - peginterferon alfa-2a 135 µg/ml - solution for injection - 135 mcg/ml - active: peginterferon alfa-2a 135 µg/ml excipient: acetic acid benzyl alcohol glacial acetic acid sodium acetate 10% soln polysorbate 80 sodium acetate trihydrate sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - peginterferon alfa-2a 360 µg/ml - solution for injection - 180 mcg/0.5ml - active: peginterferon alfa-2a 360 µg/ml excipient: acetic acid benzyl alcohol glacial acetic acid sodium acetate soln 10% polysorbate 80 sodium acetate trihydrate sodium chloride water for injection - latest regulatory activity

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - peginterferon alfa-2a 180 µg/ml - solution for injection - 180 mcg/ml - active: peginterferon alfa-2a 180 µg/ml excipient: acetic acid benzyl alcohol glacial acetic acid sodium acetate soln 10% polysorbate 80 sodium acetate trihydrate sodium chloride water for injection

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).,

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

merck sharp & dohme australia pty ltd - peginterferon alfa-2b -